RELIANCE: Moringa in Lactation and Early Childhood

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age7-99
SponsorPhilip Kern

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Carrier and Moringa Leaf PowderExperimental treatment 1 intervention
Group B: CarrierPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Human Milk Production (milk volume)

Human milk production measured by 24-hour infant test-weighing to estimate daily milk volume.

Time frame
Baseline, 2 months, 4 months, 6 months, 9 months and 12 months
2

Duration of Exclusive Breastfeeding

Duration of exclusive breastfeeding assessed by maternal report.

Time frame
Up to 12 months

Secondary outcomes

1

Maternal Serum Levels of Estradiol

Maternal serum estradiol concentration measured from blood samples to assess hormonal changes associated with lactation following moringa supplementation compared with placebo.

Time frame
Baseline, 2 months, 4 months, 6 months and 12 months
2

Maternal Serum Levels of Progesterone

Maternal serum progesterone concentration measured from blood samples to assess hormonal changes associated with lactation following moringa supplementation compared with placebo

Time frame
Baseline, 2 months, 4 months, 6 months, and 12 months
3

Maternal Serum Levels of Prolactin

Maternal serum prolactin concentration measured from blood samples to assess hormonal changes associated with lactation following moringa supplementation compared with placebo

Time frame
Baseline, 2 months, 4 months, 6 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philip Kern

Lead sponsor

University of Kentucky

Sponsor institution

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