Breastfeeding
Conditions
Keywords
maternal and child health
Brief summary
The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.
Interventions
capsule ingestion
capsule ingestion
Sponsors
Study design
Intervention model description
placebo controlled randomized controlled trial
Eligibility
Inclusion criteria
Mom YES: * willing to breastfeed or pump for one week * willing to complete study activities (at minimum measure 24 hour pumped volume at start and end of capsules, take capsules daily, and answer questions) * has access to breastpump (in hospital and/or home) * English speaking * 18 years or older * Gave birth between 2-6 weeks prior to study start NO: * taking metoclopramide (trade name Reglan) currently or within 2 weeks of enrollment * taking moringa regularly or within 2 weeks of enrollment * breast surgery (amplification, reduction, or other) * breast condition: Insufficient Glandular tissue * unprescribed or street drug use at any point in pregnancy, or enrolled in rehab program or receiving addiction therapy * refuses to take 4 capsules twice daily within 2 days of study start * wishes to withdraw within 2 days of study start Infant YES: * 28-36 and 7 weeks gestation (ie 37 weeks is too old) * 2-6 weeks old * singleton birth NO: · any condition where breastmilk is clinically contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Milk output | 7 days | 24 hour milk output at 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % mother's own milk consumed by infant | 7 days | % of mother's own milk (over total enteral nutrition) consumed by infant at 7 days |
Countries
United States