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MalnutritionPhase 3iLiNS-DOSENCT00945698

Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)

A Phase 3 study testing Lipid-based nutrient supplement, 10gM, Lipid-based nutrient supplement, 20gM and Lipid-based Nutrient Supplement, 20gNoM in people with Malnutrition, run by Tampere University at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Read more about this study

Who is it for?
Ages 167 to 197 daysHealthy volunteers can take part
Conditions the study is for
Malnutrition
What is being tested?
Lipid-based nutrient supplement, 10gM, Lipid-based nutrient supplement, 20gM and Lipid-based Nutrient Supplement, 20gNoM
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,920 participants
Where
1 siteMalawi
Study dates
Nov 2009to Aug 2014
Phase
Phase 3
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 167 to 197 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Signed informed consent from at least one guardian
  • Age 5.50 months to 6.49 months
  • Availability during the period of the study.
  • Permanent resident of Mangochi District Hospital or Namwera Health Centre catchment area

Who cannot join

  • Weight for length Z score (WLZ) < -2.0
  • Presence of oedema
  • Severe anaemia (Hb<50 g / l)
  • Severe illness warranting hospital referral
  • History of allergy towards peanut
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Concurrent participation in any other clinical trial

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • University of Malawi, College of Medicine

    Mangochi

Other trials in Malawi

About this study

Official title: A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Read the detailed description

Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Conditions
Malnutrition
Being tested
Lipid-based nutrient supplement, 10gM, Lipid-based nutrient supplement, 20gM, Lipid-based Nutrient Supplement, 20gNoM, Lipid-based nutrient supplement, 40gM, Lipid-based Nutrient Supplement, 40gNoM
Keywords
Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation, Efficacy
Medical subject headings
Malnutrition, Growth Disorders, Failure to Thrive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipid-based nutrient supplement, 10gMDietary supplement

    • 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

  • Lipid-based nutrient supplement, 20gMDietary supplement

    • 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

  • Lipid-based Nutrient Supplement, 20gNoMDietary supplement

    • 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

  • Lipid-based nutrient supplement, 40gMDietary supplement

    • 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

  • Lipid-based Nutrient Supplement, 40gNoMDietary supplement

    • 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

  • Maize-soy flourDietary supplement

    • No food supplement during the primary trial period (6 to 18 months of age)
    • 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
    • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Study groups in NCT00945698
Study groupRoleWhat they receive
ST-DI (Delayed intervention)Other* 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Maize-soy flour
LNS-10gMExperimental* 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Lipid-based nutrient supplement, 10gM
LNS-20gMExperimental* 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Lipid-based nutrient supplement, 20gM
LNS-20gNoMExperimental* 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM
LNS-40gMExperimental* 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Lipid-based nutrient supplement, 40gM
LNS-40gNoMExperimental* 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age * Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Receives: Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age

    Measured: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  2. Incidence of serious adverse events during the study period

    Measured: 12 months after enrollment (age 18 months)

Secondary outcomes (12)

  1. Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores

    Measured: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  2. Incidence of stunting, underweight, and wasting

    Measured: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  3. Prevalence of reduced appetite

    Measured: Daily assessment during 12 month supplementation

  4. Energy intake from complementary foods

    Measured: 3 and 9 months after enrollment (age 9 and 15 months)

  5. Incidence of laboratory-confirmed malaria infection

    Measured: 12 months after enrollment (age 18 months)

  6. Incidence of caregiver-reported morbidity

    Measured: Daily assessment during 12 month supplementation

  7. Immune function (measured by humoral immunity towards measles vaccination)

    Measured: 12 months after enrollment (age 18 months)

  8. Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine

    Measured: 12 months after enrollment (age 18 months)

  9. Proportion with anaemia at 18 months of age

    Measured: 12 months after enrollment (age 18 months)

  10. Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)

    Measured: 12 months after enrollment (age 18 months)

  11. Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months)

    Measured: Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months

  12. Incidence of all adverse events during the study period

    Measured: 12 months after enrollment (age 18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionAug 2012
  4. Study completionAug 2014

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,920 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00945698
Sponsor's protocol ID
iLiNS-DOSE
Acronym
iLiNS-DOSE
Status last verified
May 2015
First submitted
21 Jul 2009
Last updated
27 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38. doi: 10.1093/ajcn/87.4.929.

    PubMed 18400716

  • Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619.

    PubMed 18606932

  • Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.

    PubMed 19056572

  • Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K. Does anthropometric status at 6 months predict the over-dispersion of malaria infections in children aged 6-18 months? A prospective cohort study. Malar J. 2019 Apr 22;18(1):143. doi: 10.1186/s12936-019-2778-y.

    PubMed 31010435

  • Bendabenda J, Patson N, Hallamaa L, Mbotwa J, Mangani C, Phuka J, Prado EL, Cheung YB, Ashorn U, Dewey KG, Ashorn P, Maleta K. The association of malaria morbidity with linear growth, hemoglobin, iron status, and development in young Malawian children: a prospective cohort study. BMC Pediatr. 2018 Dec 28;18(1):396. doi: 10.1186/s12887-018-1378-2.

    PubMed 30593271

  • Kumwenda C, Hemsworth J, Phuka J, Ashorn U, Arimond M, Maleta K, Prado EL, Haskell MJ, Dewey KG, Ashorn P. Association between breast milk intake at 9-10 months of age and growth and development among Malawian young children. Matern Child Nutr. 2018 Jul;14(3):e12582. doi: 10.1111/mcn.12582. Epub 2018 Jan 19.

    PubMed 29349922

  • Adams 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 28978680

  • Prado EL, Abbeddou S, Adu-Afarwuah S, Arimond M, Ashorn P, Ashorn U, Brown KH, Hess SY, Lartey A, Maleta K, Ocansey E, Ouedraogo JB, Phuka J, Some JW, Vosti SA, Yakes Jimenez E, Dewey KG. Linear Growth and Child Development in Burkina Faso, Ghana, and Malawi. Pediatrics. 2016 Aug;138(2):e20154698. doi: 10.1542/peds.2015-4698.

    PubMed 27474016

  • Bendabenda J, Alho L, Ashorn U, Cheung YB, Dewey KG, Vosti SA, Phuka J, Maleta K, Ashorn P. The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial. Public Health Nutr. 2016 Jul;19(10):1893-903. doi: 10.1017/S1368980016000331. Epub 2016 Mar 9.

    PubMed 26956611

  • Hemsworth J, Kumwenda C, Arimond M, Maleta K, Phuka J, Rehman AM, Vosti SA, Ashorn U, Filteau S, Dewey KG, Ashorn P, Ferguson EL. Lipid-Based Nutrient Supplements Increase Energy and Macronutrient Intakes from Complementary Food among Malawian Infants. J Nutr. 2016 Feb;146(2):326-34. doi: 10.3945/jn.115.215327. Epub 2016 Jan 6.

    PubMed 26740684

  • Maleta KM, Phuka J, Alho L, Cheung YB, Dewey KG, Ashorn U, Phiri N, Phiri TE, Vosti SA, Zeilani M, Kumwenda C, Bendabenda J, Pulakka A, Ashorn P. Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi. J Nutr. 2015 Aug;145(8):1909-15. doi: 10.3945/jn.114.208181. Epub 2015 Jun 10.

    PubMed 26063066

  • Ashorn U, Alho L, Arimond M, Dewey KG, Maleta K, Phiri N, Phuka J, Vosti SA, Zeilani M, Ashorn P. Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common. J Nutr. 2015 Jul;145(7):1588-95. doi: 10.3945/jn.114.209593. Epub 2015 May 20.

    PubMed 25995276

  • Kumwenda C, Dewey KG, Hemsworth J, Ashorn P, Maleta K, Haskell MJ. Lipid-based nutrient supplements do not decrease breast milk intake of Malawian infants. Am J Clin Nutr. 2014 Mar;99(3):617-23. doi: 10.3945/ajcn.113.076588. Epub 2013 Dec 24.

    PubMed 24368436

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lipid-based nutrient supplement, 10gM, Lipid-based nutrient supplement, 20gM and Lipid-based Nutrient Supplement, 20gNoM in people with Malnutrition, run by Tampere University at 1 site in Malawi.

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 4 inclusion and 7 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 27 May 2015. 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 Malawi. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)). The study lists 2 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 NCT00945698, which also lists 13 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 27 May 2015.

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