RELIANCE: Moringa in Lactation and Early Childhood
Starting soon · Not applicable
Conditions studied: Breast Feeding, Lactation
In brief
This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years. Women must be \>18 years of age, ≤ 21 days postpartum and currently lactating at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk. After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, 6, 9 and 12 months. Serum from mothers will be collected at recruitment, 2, 4, 6,and 12 months; infant serum will be collected by capillary sample at recruitment and approximately at 2, 6, 12, and 24 months. Infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. Dietary recall: the foods and drinks consumed by mothers in the past month prior to each milk sample. Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.
Key facts
- Study ID
- NCT07605091
- Run by
- Philip Kern
- People needed
- 100
- Starts
- 2026-11-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 0 and older, up to 99. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Mothers: Inclusion criteria - >18 years of age, s/p delivery of a healthy infant, and planning breast feeding.
- Infants: must be born at term (=37-42 weeks), singleton birth, lactating, age 7-21 days at enrollment
You may not qualify if…
- Mothers - women reporting regular consumption of moringa in the last month (>1 time weekly), unable to consume moringa or unable to complete study activities within the first two weeks.
- Mothers - Women with a contraindication to Moringa use (blood thinners, levothyroxine, antihypertensive treatments, insulin dependency).
- Infants - significant congenital disease, are unable to feed orally.
Where it is running
- SUNDY Downstate — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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