MalnutritionRDNSNCT01715038
Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh
A study testing LNS-PLW, LNS-Child and MNP in people with Malnutrition, run by University of California, Davis at 1 site in Bangladesh.
Trial summary
The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and… Read more about this study
- Who is it for?
- Ages 6 months to 49 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- LNS-PLW, LNS-Child and MNP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,011 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Gestational age ≤ 20 weeks
- Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)
Who cannot join
- Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study
The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.
Read the detailed description
This study is a cluster-randomized controlled trial with four study "arms", implemented within the context of the Community Health and Development Program (CHDP) run by the World Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data collection is longitudinal, starting with the identification of women in early pregnancy who are eligible to enter the study, and continuing, with follow-up of the child, until 24 months post-partum. A final follow-up visit will occur when the child is 36 months old to update contact information; no outcomes data will be collected at that final visit. The investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and lactation on maternal health and nutrition outcomes (including anthropometric and micronutrient status), morbidity and birth outcomes in comparison to mothers who receive iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating the effect of three different home-fortification approaches (arms a-c, below) on child health and nutrition outcomes including anthropometric status, micronutrient status, anemia, and motor and cognitive development, in comparison to a control arm not receiving a home fortification intervention.
Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP interventions as part of the CHDP compared to standard CHDP program delivery will be documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by selected caregivers and male heads of households will be assessed at baseline and again at various points during the intervention period.
A process evaluation of the LNS and MNP interventions, and of the services provided to the control group, within the CHDP will be conducted to: 1) Document and evaluate the processes needed for implementation of interventions that provide a nutrient supplement such as LNS or MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study results and identify important facilitators and barriers to success of the nutrition intervention, which can be used to improve the effectiveness of current CHDP programs and future similar programs that include the scaling-up of LNS or MNP.
A post-intervention follow-up assessment for participants in the RDNS trial was added to the study protocol in November 2015. The intervention stopped when the study children turned 24 months old, and follow-up visits to update contact information were conducted when the children turned 36 months old. Thereafter, when the study children are between 40 and 52 months old, the follow-up assessment includes anthropometric and cognitive development assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and buccal swab samples at the local clinics; for the mothers the follow-up includes anthropometric measurements, measurement of blood pressure and collection of fasting blood samples (finger prick). The follow-up also includes anthropometric measurements of the younger siblings, as well as a home visit to collect information on socioeconomic status, food security, hospitalizations of mother or child, developmental stimulation in the home, child food preferences and retrospective perceptions about the trial interventions.
Follow-up outcomes:
Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height. Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.
Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial), executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24 months of age. Preferences for sweet and fatty foods.
Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.
- Conditions
- Malnutrition
- Being tested
- LNS-PLW, LNS-Child, MNP, IFA
- Keywords
- malnutrition, stunting, LNS, micronutrient powder, hemoglobin
- Medical subject headings
- Malnutrition, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNS-PLWDietary supplement
Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)
Daily dose of LNS-PLW will be 20 g, packaged in one sachet
LNS-ChildDietary supplement
Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for infants and young children (LNS-Child)
Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets
MNPDietary supplement
Dietary supplement: Micronutrient powder
Micronutrient powder for infants and young children (MNP)
The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.
IFADietary supplement
Dietary supplement: Iron and folic acid nutrient supplement
Iron-folic acid tablets for pregnant and lactating women
Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive | Experimental | "Comprehensive" LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age). Receives: Dietary Supplement: LNS-PLW; Dietary Supplement: LNS-Child |
| Child-only LNS | Experimental | "Child-only" LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. Receives: Dietary Supplement: LNS-Child; Dietary Supplement: IFA |
| Child-only MNP | Experimental | "Child-only" MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. Receives: Dietary Supplement: MNP; Dietary Supplement: IFA |
| Control: IFA | Active comparator | Control: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. Receives: Dietary Supplement: IFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements).
Birth length
Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Child linear growth status at 24 months
Linear growth (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Secondary outcomes (27)
Change in maternal weight between baseline and 36 wk gestation
Gestational weight gain from enrollment (by 20 weeks of gestation) through 36 weeks of gestation (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 12-20 and 36 weeks of gestation
Pre-eclampsia
Prevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: 36 weeks of gestation
Duration of gestation
Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Day 0
Pre-term delivery
Prevalence of pre-term delivery (delivery at <37 gestational weeks) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Day 0
Low birth weight
Prevalence of low birth weight (birth weight < 2500 g) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Small for gestational age (SGA)
Prevalence of SGA (birth weight < 10th percentile) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Newborn stunting
Prevalence of newborn stunting (length-for-age z-score <-2) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
BMI z score at birth
BMI z score at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Head circumference (HC) at birth
Head circumference at birth of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Small head size at birth
Prevalence of small head size (HC-z-score <-2) at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: Within 48 hours (or back calculated from later measurements)
Change in maternal weight between 42 d and 6 mo postpartum
Postpartum weight change from 42 days through 6 mo postpartum (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), for time of year when outcome was assessed
Measured: Between 42 d and 6 mo postpartum
Change in maternal iodine status between baseline and 6 mo postpartum
Prevalence of iodine deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron status between baseline and 6 months postpartum
Prevalence of iron deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron-deficiency anemia between baseline and 6 months postpartum
Prevalence of iron-deficiency anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal anemia between baseline and 6 months postpartum
Prevalence of anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal vitamin A status between baseline and 6 months postpartum
Prevalence of vitamin A deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal depressive symptoms between baseline and 6 months postpartum
Prevalence of depression during lactation (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Measured: Between 10-20 weeks of gestation and 6 months postpartum
Child hemoglobin concentration at 18 months of age
Hemoglobin concentration (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 18 months
Child iron status at 18 months of age
Prevalence of iron deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 18 months
Child vitamin A status at 18 months of age
Prevalence of vitamin A deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 18 months
Child anemia status at 18 months of age
Prevalence of anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 18 months
Child iron-deficiency anemia status at 18 months of age
Prevalence of iron-deficiency anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 18 months
Wasting at 24 months of age
Prevalence of wasting (weight-for-length z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Head circumference at 24 months of age
Head circumference of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Stunting at 24 months of age
Prevalence of stunting (length-for-age z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Child motor development at 24 months of age
Motor development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Child cognitive development at 24 months of age
Cognitive development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health International 360, International Centre for Diarrhoeal Disease Research, Bangladesh, LAMB Project
- Responsible party
- Sponsor
- Investigators
- Kathryn G Dewey, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715038
- Sponsor's protocol ID
- 252233
- Other IDs
- PR-10044
- Acronym
- RDNS
- Status last verified
- May 2017
- First submitted
- 18 Oct 2012
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dewey KG, Arnold CD, Matias SL, Adu-Afarwuah S, Demuyakor ME, Kumordzie SM, Mridha MK, Oaks BM, Okronipa H, Tofail F. Sustained effects of combined maternal and child small-quantity lipid-based nutrient supplements in early life on growth and developmental outcomes at preschool age: an individual participant data analysis of randomized trials in Ghana and Bangladesh. Am J Clin Nutr. 2026 Jun;123(6):101310. doi: 10.1016/j.ajcnut.2026.101310. Epub 2026 Apr 8.
PubMed 41962744Roy A, Hossain MM, Ullah MB, Mridha MK. Maternal and neonatal peripartum factors associated with late initiation of breast feeding in Bangladesh: a secondary analysis. BMJ Open. 2022 May 18;12(5):e051004. doi: 10.1136/bmjopen-2021-051004.
PubMed 35584874Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Paul RR, Dewey KG. Factors associated with diarrhea and acute respiratory infection in children under two years of age in rural Bangladesh. BMC Pediatr. 2019 Oct 27;19(1):386. doi: 10.1186/s12887-019-1738-6.
PubMed 31656181Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Dewey KG. Provision of Pre- and Postnatal Nutritional Supplements Generally Did Not Increase or Decrease Common Childhood Illnesses in Bangladesh: A Cluster-Randomized Effectiveness Trial. J Nutr. 2019 Jul 1;149(7):1271-1281. doi: 10.1093/jn/nxz059.
PubMed 31162588Matias SL, Mridha MK, Young RT, Hussain S, Dewey KG. Daily Maternal Lipid-Based Nutrient Supplementation with 20 mg Iron, Compared with Iron and Folic Acid with 60 mg Iron, Resulted in Lower Iron Status in Late Pregnancy but Not at 6 Months Postpartum in Either the Mothers or Their Infants in Bangladesh. J Nutr. 2018 Oct 1;148(10):1615-1624. doi: 10.1093/jn/nxy161.
PubMed 30204885Matias SL, Mridha MK, Young RT, Khan MSA, Siddiqui Z, Ullah MB, Vosti SA, Dewey KG. Prenatal and Postnatal Supplementation with Lipid-Based Nutrient Supplements Reduces Anemia and Iron Deficiency in 18-Month-Old Bangladeshi Children: A Cluster-Randomized Effectiveness Trial. J Nutr. 2018 Jul 1;148(7):1167-1176. doi: 10.1093/jn/nxy078.
PubMed 29901736Adams KP, Ayifah E, Phiri TE, Mridha MK, Adu-Afarwuah S, Arimond M, Arnold CD, Cummins J, Hussain S, Kumwenda C, Matias SL, Ashorn U, Lartey A, Maleta KM, Vosti SA, Dewey KG. Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings. J Nutr. 2017 Dec;147(12):2309-2318. doi: 10.3945/jn.117.257386. Epub 2017 Oct 4.
PubMed 28978680Mridha MK, Matias SL, Paul RR, Hussain S, Sarker M, Hossain M, Peerson JM, Vosti SA, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Do Not Affect Pregnancy or Childbirth Complications or Cesarean Delivery in Bangladesh: A Cluster-Randomized Controlled Effectiveness Trial. J Nutr. 2017 Sep;147(9):1776-1784. doi: 10.3945/jn.117.248880. Epub 2017 Jul 19.
PubMed 28724657Mridha MK, Matias SL, Paul RR, Hussain S, Khan MSA, Siddiqui Z, Ullah B, Sarker M, Hossain M, Young RT, Arnold CD, Dewey KG. Daily Consumption of Lipid-Based Nutrient Supplements Containing 250 mug Iodine Does Not Increase Urinary Iodine Concentrations in Pregnant and Postpartum Women in Bangladesh. J Nutr. 2017 Aug;147(8):1586-1592. doi: 10.3945/jn.117.248963. Epub 2017 Jun 14.
PubMed 28615379Matias SL, Mridha MK, Tofail F, Arnold CD, Khan MS, Siddiqui Z, Ullah MB, Dewey KG. Home fortification during the first 1000 d improves child development in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):958-969. doi: 10.3945/ajcn.116.150318. Epub 2017 Mar 8.
PubMed 28275128Dewey KG, Mridha MK, Matias SL, Arnold CD, Cummins JR, Khan MS, Maalouf-Manasseh Z, Siddiqui Z, Ullah MB, Vosti SA. Lipid-based nutrient supplementation in the first 1000 d improves child growth in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):944-957. doi: 10.3945/ajcn.116.147942. Epub 2017 Mar 8.
PubMed 28275125Matias SL, Mridha MK, Paul RR, Hussain S, Vosti SA, Arnold CD, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Affect Maternal Anthropometric Indicators Only in Certain Subgroups of Rural Bangladeshi Women. J Nutr. 2016 Sep;146(9):1775-82. doi: 10.3945/jn.116.232181. Epub 2016 Jul 20.
PubMed 27440259Harding KL, Matias SL, Mridha MK, Moniruzzaman M, Vosti SA, Hussain S, Dewey KG, Stewart CP. Adherence to recommendations on lipid-based nutrient supplement and iron and folic acid tablet consumption among pregnant and lactating women participating in a community health programme in northwest Bangladesh. Matern Child Nutr. 2017 Jan;13(1):e12252. doi: 10.1111/mcn.12252. Epub 2016 Feb 22.
PubMed 26898720Mridha MK, Matias SL, Chaparro CM, Paul RR, Hussain S, Vosti SA, Harding KL, Cummins JR, Day LT, Saha SL, Peerson JM, Dewey KG. Lipid-based nutrient supplements for pregnant women reduce newborn stunting in a cluster-randomized controlled effectiveness trial in Bangladesh. Am J Clin Nutr. 2016 Jan;103(1):236-49. doi: 10.3945/ajcn.115.111336. Epub 2015 Nov 25.
PubMed 26607935
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study
- ClinicalTrials.gov ID
- NCT01715038
- Acronym / sponsor ID
- RDNS / 252233
- Conditions
- Malnutrition
- Keywords
- malnutrition, stunting, LNS, micronutrient powder, hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,011 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Family Health International 360, International Centre for Diarrhoeal Disease Research, Bangladesh, LAMB Project
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.
Detailed description
This study is a cluster-randomized controlled trial with four study "arms", implemented within the context of the Community Health and Development Program (CHDP) run by the World Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data collection is longitudinal, starting with the identification of women in early pregnancy who are eligible to enter the study, and continuing, with follow-up of the child, until 24 months post-partum. A final follow-up visit will occur when the child is 36 months old to update contact information; no outcomes data will be collected at that final visit. The investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and lactation on maternal health and nutrition outcomes (including anthropometric and micronutrient status), morbidity and birth outcomes in comparison to mothers who receive iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating the effect of three different home-fortification approaches (arms a-c, below) on child health and nutrition outcomes including anthropometric status, micronutrient status, anemia, and motor and cognitive development, in comparison to a control arm not receiving a home fortification intervention.
Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP interventions as part of the CHDP compared to standard CHDP program delivery will be documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by selected caregivers and male heads of households will be assessed at baseline and again at various points during the intervention period.
A process evaluation of the LNS and MNP interventions, and of the services provided to the control group, within the CHDP will be conducted to: 1) Document and evaluate the processes needed for implementation of interventions that provide a nutrient supplement such as LNS or MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study results and identify important facilitators and barriers to success of the nutrition intervention, which can be used to improve the effectiveness of current CHDP programs and future similar programs that include the scaling-up of LNS or MNP.
A post-intervention follow-up assessment for participants in the RDNS trial was added to the study protocol in November 2015. The intervention stopped when the study children turned 24 months old, and follow-up visits to update contact information were conducted when the children turned 36 months old. Thereafter, when the study children are between 40 and 52 months old, the follow-up assessment includes anthropometric and cognitive development assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and buccal swab samples at the local clinics; for the mothers the follow-up includes anthropometric measurements, measurement of blood pressure and collection of fasting blood samples (finger prick). The follow-up also includes anthropometric measurements of the younger siblings, as well as a home visit to collect information on socioeconomic status, food security, hospitalizations of mother or child, developmental stimulation in the home, child food preferences and retrospective perceptions about the trial interventions.
Follow-up outcomes:
Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height. Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.
Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial), executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24 months of age. Preferences for sweet and fatty foods.
Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comprehensive | Experimental | Dietary Supplement: LNS-PLW, Dietary Supplement: LNS-Child"Comprehensive" LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age). |
| Child-only LNS | Experimental | Dietary Supplement: LNS-Child, Dietary Supplement: IFA"Child-only" LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. |
| Child-only MNP | Experimental | Dietary Supplement: MNP, Dietary Supplement: IFA"Child-only" MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. |
| Control: IFA | Active comparator | Dietary Supplement: IFAControl: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Gestational age ≤ 20 weeks
- Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)
Key exclusion criteria (1 listed)
- Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNS-PLWDietary supplement: Lipid-based nutrient supplement Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW) Daily dose of LNS-PLW will be 20 g, packaged in one sachet | Dietary supplement | Comprehensive |
| LNS-ChildDietary supplement: Lipid-based nutrient supplement Lipid-based nutrient supplement for infants and young children (LNS-Child) Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets | Dietary supplement | Child-only LNS, Comprehensive |
| MNPDietary supplement: Micronutrient powder Micronutrient powder for infants and young children (MNP) The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet. | Dietary supplement | Child-only MNP |
| IFADietary supplement: Iron and folic acid nutrient supplement Iron-folic acid tablets for pregnant and lactating women Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid | Dietary supplement | Child-only LNS, Child-only MNP, Control: IFA |
Primary outcome
Birth weight
Time frame: Within 48 hours (or back calculated from later measurements).
Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Birth length
Time frame: Within 48 hours (or back calculated from later measurements)
Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child linear growth status at 24 months
Time frame: 24 months
Linear growth (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
27 secondary outcomes
Change in maternal weight between baseline and 36 wk gestation
Time frame: Between 12-20 and 36 weeks of gestation
Pre-eclampsia
Time frame: 36 weeks of gestation
Duration of gestation
Time frame: Day 0
Pre-term delivery
Time frame: Day 0
Low birth weight
Time frame: Within 48 hours (or back calculated from later measurements)
Small for gestational age (SGA)
Time frame: Within 48 hours (or back calculated from later measurements)
Newborn stunting
Time frame: Within 48 hours (or back calculated from later measurements)
BMI z score at birth
Time frame: Within 48 hours (or back calculated from later measurements)
Head circumference (HC) at birth
Time frame: Within 48 hours (or back calculated from later measurements)
Small head size at birth
Time frame: Within 48 hours (or back calculated from later measurements)
Change in maternal weight between 42 d and 6 mo postpartum
Time frame: Between 42 d and 6 mo postpartum
Change in maternal iodine status between baseline and 6 mo postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron status between baseline and 6 months postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron-deficiency anemia between baseline and 6 months postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal anemia between baseline and 6 months postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal vitamin A status between baseline and 6 months postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal depressive symptoms between baseline and 6 months postpartum
Time frame: Between 10-20 weeks of gestation and 6 months postpartum
Child hemoglobin concentration at 18 months of age
Time frame: 18 months
Child iron status at 18 months of age
Time frame: 18 months
Child vitamin A status at 18 months of age
Time frame: 18 months
Child anemia status at 18 months of age
Time frame: 18 months
Child iron-deficiency anemia status at 18 months of age
Time frame: 18 months
Wasting at 24 months of age
Time frame: 24 months
Head circumference at 24 months of age
Time frame: 24 months
Stunting at 24 months of age
Time frame: 24 months
Child motor development at 24 months of age
Time frame: 24 months
Child cognitive development at 24 months of age
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 41962744Dewey KG, Arnold CD, Matias SL, Adu-Afarwuah S, Demuyakor ME, Kumordzie SM, Mridha MK, Oaks BM, Okronipa H, Tofail F. Sustained effects of combined maternal and child small-quantity lipid-based nutrient supplements in early life on growth and developmental outcomes at preschool age: an individual participant data analysis of randomized trials in Ghana and Bangladesh. Am J Clin Nutr. 2026 Jun;123(6):101310. doi: 10.1016/j.ajcnut.2026.101310. Epub 2026 Apr 8.
- Derived from this study: PubMed 35584874Roy A, Hossain MM, Ullah MB, Mridha MK. Maternal and neonatal peripartum factors associated with late initiation of breast feeding in Bangladesh: a secondary analysis. BMJ Open. 2022 May 18;12(5):e051004. doi: 10.1136/bmjopen-2021-051004.
- Derived from this study: PubMed 31656181Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Paul RR, Dewey KG. Factors associated with diarrhea and acute respiratory infection in children under two years of age in rural Bangladesh. BMC Pediatr. 2019 Oct 27;19(1):386. doi: 10.1186/s12887-019-1738-6.
- Derived from this study: PubMed 31162588Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Dewey KG. Provision of Pre- and Postnatal Nutritional Supplements Generally Did Not Increase or Decrease Common Childhood Illnesses in Bangladesh: A Cluster-Randomized Effectiveness Trial. J Nutr. 2019 Jul 1;149(7):1271-1281. doi: 10.1093/jn/nxz059.
- Derived from this study: PubMed 30204885Matias SL, Mridha MK, Young RT, Hussain S, Dewey KG. Daily Maternal Lipid-Based Nutrient Supplementation with 20 mg Iron, Compared with Iron and Folic Acid with 60 mg Iron, Resulted in Lower Iron Status in Late Pregnancy but Not at 6 Months Postpartum in Either the Mothers or Their Infants in Bangladesh. J Nutr. 2018 Oct 1;148(10):1615-1624. doi: 10.1093/jn/nxy161.
- Derived from this study: PubMed 29901736Matias SL, Mridha MK, Young RT, Khan MSA, Siddiqui Z, Ullah MB, Vosti SA, Dewey KG. Prenatal and Postnatal Supplementation with Lipid-Based Nutrient Supplements Reduces Anemia and Iron Deficiency in 18-Month-Old Bangladeshi Children: A Cluster-Randomized Effectiveness Trial. J Nutr. 2018 Jul 1;148(7):1167-1176. doi: 10.1093/jn/nxy078.
- Derived from this study: PubMed 28978680Adams KP, Ayifah E, Phiri TE, Mridha MK, Adu-Afarwuah S, Arimond M, Arnold CD, Cummins J, Hussain S, Kumwenda C, Matias SL, Ashorn U, Lartey A, Maleta KM, Vosti SA, Dewey KG. Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings. J Nutr. 2017 Dec;147(12):2309-2318. doi: 10.3945/jn.117.257386. Epub 2017 Oct 4.
- Derived from this study: PubMed 28724657Mridha MK, Matias SL, Paul RR, Hussain S, Sarker M, Hossain M, Peerson JM, Vosti SA, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Do Not Affect Pregnancy or Childbirth Complications or Cesarean Delivery in Bangladesh: A Cluster-Randomized Controlled Effectiveness Trial. J Nutr. 2017 Sep;147(9):1776-1784. doi: 10.3945/jn.117.248880. Epub 2017 Jul 19.
- Derived from this study: PubMed 28615379Mridha MK, Matias SL, Paul RR, Hussain S, Khan MSA, Siddiqui Z, Ullah B, Sarker M, Hossain M, Young RT, Arnold CD, Dewey KG. Daily Consumption of Lipid-Based Nutrient Supplements Containing 250 mug Iodine Does Not Increase Urinary Iodine Concentrations in Pregnant and Postpartum Women in Bangladesh. J Nutr. 2017 Aug;147(8):1586-1592. doi: 10.3945/jn.117.248963. Epub 2017 Jun 14.
- Derived from this study: PubMed 28275128Matias SL, Mridha MK, Tofail F, Arnold CD, Khan MS, Siddiqui Z, Ullah MB, Dewey KG. Home fortification during the first 1000 d improves child development in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):958-969. doi: 10.3945/ajcn.116.150318. Epub 2017 Mar 8.
- Derived from this study: PubMed 28275125Dewey KG, Mridha MK, Matias SL, Arnold CD, Cummins JR, Khan MS, Maalouf-Manasseh Z, Siddiqui Z, Ullah MB, Vosti SA. Lipid-based nutrient supplementation in the first 1000 d improves child growth in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):944-957. doi: 10.3945/ajcn.116.147942. Epub 2017 Mar 8.
- Derived from this study: PubMed 27440259Matias SL, Mridha MK, Paul RR, Hussain S, Vosti SA, Arnold CD, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Affect Maternal Anthropometric Indicators Only in Certain Subgroups of Rural Bangladeshi Women. J Nutr. 2016 Sep;146(9):1775-82. doi: 10.3945/jn.116.232181. Epub 2016 Jul 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn G Dewey, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LNS-PLW, LNS-Child and MNP in people with Malnutrition, run by University of California, Davis at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: Within 48 hours (or back calculated from later measurements).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715038, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.