MedTrace Logo

RELIANCE: Moringa in Lactation and Early Childhood

NCT07605091 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Breast Feeding
  • Lactation

Interventions

DIETARY_SUPPLEMENT

Moringa Leaf Powder

Participants randomized to Moringa will consume 10 grams each day of the Moringa leaf powder mixed into porridge.

OTHER

Carrier

Participants randomized to the control will be given porridge without Moringa.

Sponsors & Collaborators

  • Philip Kern

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-09-30
Completion
2030-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605091 on ClinicalTrials.gov