Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

April 22, 2015

Completed

9 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed

1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed

Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

April 22, 2015

Last Update Submit

September 4, 2015

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (5)

Change in Cobalamin (vitamin B12) in Breast Milk
We are observing the change in breast milk vitamin B12 over the course of 8 hours.
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.
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.
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.
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.
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
Measured once prior to first study visit (week 1)
Maternal pyridoxal (vitamin B6) status
Measured once prior to first study visit (week 1)
Maternal riboflavin (vitamin B2) status
Measured once prior to first study visit (week 1)
Maternal niacin (vitamin B3) status
Measured once prior to first study visit (week 1)
Maternal thiamin (vitamin B1) status
Measured once prior to first study visit (week 1)
+1 more secondary outcomes

Study Arms (6)

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