RELIANCE: Moringa in Lactation and Early Childhood

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Philip Kern
Study ID
NCT07605091
Status
Not Yet Recruiting

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Conditions

  • Breast Feeding
  • Lactation

Eligibility Criteria

Sex
FEMALE
Age
7 Days - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Moringa Leaf Powder — DIETARY_SUPPLEMENT
    Participants randomized to Moringa will consume 10 grams each day of the Moringa leaf powder mixed into porridge.
  • Carrier — OTHER
    Participants randomized to the control will be given porridge without Moringa.

Study Details

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, ≤ 30 days postpartum and exclusively breastfeeding 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, and 6 months. Serum from mothers will be collected at recruitment, 2, 6,and 9 months; infant serum will be collected by capillary sample at recruitment and approximately at 4, 6, 12, 18, and 24 months. Infant hemoglobin and infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. 24-hour dietary recall: the foods and drinks consumed by mothers in the 24 hours 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 Dates

Start date
Nov 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Carrier and Moringa Leaf Powder
  • Placebo Comparator: Carrier

Primary Outcome Measure

Maternal Serum Levels of Estradiol [ Time Frame: Baseline, 2 months, 4 months, 6 months and 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNDY DownstateBrooklynNew York11203-

Find similar trials in Brooklyn, NY

By research site
SUNDY Downstate· Brooklyn, NY

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