MalnutritionNCT02464111
Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women
A study testing Treatment 2: Bolus (LNS) and Treatment 3: Divided Dose (LNS) in people with Malnutrition, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Treatment 2: Bolus (LNS) and Treatment 3: Divided Dose (LNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Aug 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother 18-40 years of age
- Apparently healthy, with no acute illness
- Willing to stay in clinic for breast milk sampling, and adhere to all study procedures
- 4-6 months of lactation and ≥ 8 breast feeding episodes per day (usual frequency is >20 times/day)
- Last birth was a singleton birth
- Only breastfeeding one child
- Child is 4-6 months of age
Who cannot join
- Current supplement use (iron + folic acid excepted)
- Self reported mastitis or other breast infections
- Reported problems with breastfeeding which might affect study procedures
- Last birth was premature (>4 weeks pre-term by maternal report)
- Measured body mass index (BMI) of less than 18.5 or a measured mid upper arm circumference (MUAC) of less than 12.5 cm
- Temporary- if the mother or her infant present with an acute illness, (for example flu or diarrhea,) they will be rescheduled to return on a later date when both are apparently healthy.
- Allergy to milk, milk products, or peanuts.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.
Read the detailed description
The study includes a cross sectional and an interventional component. Maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner.
The short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and LNS. Infants will be test-weighed during the LNS intervention in order to calculate the infant micronutrient intake from the control and LNS intervention days.
Mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. All mothers will receive all treatments.
The mothers will be invited to the clinic on 4 separate occasions. During the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. During the 2-4 visits, the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted milk collection will occur. Subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their meals throughout the day. Infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.
- Conditions
- Malnutrition
- Being tested
- Treatment 1: Control, Treatment 2: Bolus (LNS), Treatment 3: Divided Dose (LNS)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 1: ControlOther
No supplement provided.
Treatment 2: Bolus (LNS)Dietary supplement
One LNS supplement provided in a single bolus dose in the morning
Treatment 3: Divided Dose (LNS)Dietary supplement
One LNS supplement provided in 3 separate portions throughout the study visit
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
| Group 2 | Experimental | Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
| Group 3 | Experimental | Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
| Group 4 | Experimental | Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
| Group 5 | Experimental | Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
| Group 6 | Experimental | Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose Receives: Other: Treatment 1: Control; Dietary Supplement: Treatment 2: Bolus (LNS); Dietary Supplement: Treatment 3: Divided Dose (LNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobalamin (vitamin B12) in Breast Milk
We are observing the change in breast milk vitamin B12 over the course of 8 hours.
Measured: Breast milk cobalamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
Change in Pyridoxal (vitamin B6) in Breast Milk
We are observing the change in breast milk vitamin B6 over the course of 8 hours.
Measured: Breast milk pyridoxal will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
Change in Riboflavin (vitamin B2) in Breast Milk
We are observing the change in breast milk vitamin B2 over the course of 8 hours.
Measured: Breast milk riboflavin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Change in Niacin (vitamin B3) in Breast Milk
We are observing the change in breast milk vitamin B5 over the course of 8 hours.
Measured: Breast milk niacin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Change in Thiamin (vitamin B1) in Breast Milk
We are observing the change in breast milk vitamin B1 over the course of 8 hours.
Measured: Breast milk thiamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits/weeks 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Secondary outcomes (6)
Maternal cobalamin (vitamin B12) status
Maternal cobalamin (vitamin B12) status will be measured in blood.
Measured: Measured once prior to first study visit (week 1)
Maternal pyridoxal (vitamin B6) status
Maternal pyridoxal (vitamin B6) will be measured in blood.
Measured: Measured once prior to first study visit (week 1)
Maternal riboflavin (vitamin B2) status
Maternal riboflavin (vitamin B2) will be measured in blood.
Measured: Measured once prior to first study visit (week 1)
Maternal niacin (vitamin B3) status
Maternal niacin (vitamin B5) will be measured in blood.
Measured: Measured once prior to first study visit (week 1)
Maternal thiamin (vitamin B1) status
Maternal thiamin (vitamin B1) will be measured in blood.
Measured: Measured once prior to first study visit (week 1)
Change in Infant Milk Consumption
Infants will be test-weighed before and after each feed to calculate milk intake during the study visits. We are observing the change in breast milk intake over the course of 8 hours.
Measured: Breast milk consumption for an 8-hour period will be assessed on each of three study visit days (Visits/weeks 2, 3, and 4). Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis, Blum Center for Developing Economies, Fogarty International Center of the National Institute of Health, Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)
- Responsible party
- Sponsor
- Investigators
- Juliana A Haber, B.S., Principal investigator, USDA WHNRC, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464111
- Sponsor's protocol ID
- 723323-1
- Other IDs
- 5R25TW009343-03
- Status last verified
- Sep 2015
- First submitted
- 22 Apr 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Donohue JA, Solomons NW, Hampel D, Shahab-Ferdows S, Orozco MN, Allen LH. Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial. Am J Clin Nutr. 2020 Sep 1;112(3):669-682. doi: 10.1093/ajcn/nqaa147.
PubMed 32649760
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women
- ClinicalTrials.gov ID
- NCT02464111
- Acronym / sponsor ID
- 723323-1
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis, Blum Center for Developing Economies, Fogarty International Center of the National Institute of Health, Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Jun 2015 (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.
Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.
Detailed description
The study includes a cross sectional and an interventional component. Maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner.
The short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and LNS. Infants will be test-weighed during the LNS intervention in order to calculate the infant micronutrient intake from the control and LNS intervention days.
Mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. All mothers will receive all treatments.
The mothers will be invited to the clinic on 4 separate occasions. During the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. During the 2-4 visits, the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted milk collection will occur. Subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their meals throughout the day. Infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses |
| Group 2 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose |
| Group 3 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses |
| Group 4 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given |
| Group 5 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given |
| Group 6 | Experimental | Other: Treatment 1: Control, Dietary Supplement: Treatment 2: Bolus (LNS), Dietary Supplement: Treatment 3: Divided Dose (LNS)Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Mother 18-40 years of age
- Apparently healthy, with no acute illness
- Willing to stay in clinic for breast milk sampling, and adhere to all study procedures
- 4-6 months of lactation and ≥ 8 breast feeding episodes per day (usual frequency is >20 times/day)
- Last birth was a singleton birth
Key exclusion criteria (7 listed)
- Current supplement use (iron + folic acid excepted)
- Self reported mastitis or other breast infections
- Reported problems with breastfeeding which might affect study procedures
- Last birth was premature (>4 weeks pre-term by maternal report)
- Measured body mass index (BMI) of less than 18.5 or a measured mid upper arm circumference (MUAC) of less than 12.5 cm
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 |
|---|---|---|
| Treatment 1: ControlNo supplement provided. | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Treatment 2: Bolus (LNS)One LNS supplement provided in a single bolus dose in the morning | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Treatment 3: Divided Dose (LNS)One LNS supplement provided in 3 separate portions throughout the study visit | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Change in Cobalamin (vitamin B12) in Breast Milk
Time frame: Breast milk cobalamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
We are observing the change in breast milk vitamin B12 over the course of 8 hours.
Change in Pyridoxal (vitamin B6) in Breast Milk
Time frame: Breast milk pyridoxal will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
We are observing the change in breast milk vitamin B6 over the course of 8 hours.
Change in Riboflavin (vitamin B2) in Breast Milk
Time frame: Breast milk riboflavin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
We are observing the change in breast milk vitamin B2 over the course of 8 hours.
Change in Niacin (vitamin B3) in Breast Milk
Time frame: Breast milk niacin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
We are observing the change in breast milk vitamin B5 over the course of 8 hours.
Change in Thiamin (vitamin B1) in Breast Milk
Time frame: Breast milk thiamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits/weeks 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
We are observing the change in breast milk vitamin B1 over the course of 8 hours.
6 secondary outcomes
Maternal cobalamin (vitamin B12) status
Time frame: Measured once prior to first study visit (week 1)
Maternal pyridoxal (vitamin B6) status
Time frame: Measured once prior to first study visit (week 1)
Maternal riboflavin (vitamin B2) status
Time frame: Measured once prior to first study visit (week 1)
Maternal niacin (vitamin B3) status
Time frame: Measured once prior to first study visit (week 1)
Maternal thiamin (vitamin B1) status
Time frame: Measured once prior to first study visit (week 1)
Change in Infant Milk Consumption
Time frame: Breast milk consumption for an 8-hour period will be assessed on each of three study visit days (Visits/weeks 2, 3, and 4). Study visits 2, 3, & 4 will each be held approximately 1 week apart.
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 9 Sep 2015.
- Derived from this study: PubMed 32649760Donohue JA, Solomons NW, Hampel D, Shahab-Ferdows S, Orozco MN, Allen LH. Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial. Am J Clin Nutr. 2020 Sep 1;112(3):669-682. doi: 10.1093/ajcn/nqaa147.
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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.
Juliana A Haber, B.S. principal investigator
USDA WHNRC, UC 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 Treatment 2: Bolus (LNS) and Treatment 3: Divided Dose (LNS) in people with Malnutrition, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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 7 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 9 Sep 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 United States. 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?
Change in Cobalamin (vitamin B12) in Breast Milk (time frame: Breast milk cobalamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.). The study lists 5 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 NCT02464111, which also lists 1 linked publication.
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 9 Sep 2015.