Moringa Supplementation for Improved Milk Output
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Central trial contact
Suzanna Attia, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal