Moringa Supplementation for Improved Milk Output

Study Overview
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Brief Summary
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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.

Official Title
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Investigating the Effect of Moringa Oleifera Leaf Powder on Breastmilk Quantity and Quality: a Double Blinded Randomized Placebo-controlled Trial

Conditions
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Breastfeeding

Intervention / Treatment
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* Dietary Supplement: Moringa leaf powder
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo controlled randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moringa<br>4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days | Dietary Supplement: Moringa leaf powder<br>* capsule ingestion<br>* Other names: moringa oleifera;|
| Placebo Comparator: Control<br>comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days | Other: Placebo<br>* capsule ingestion<br>* Other names: cornstarch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Milk output | 24 hour milk output at 7 days | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % mother's own milk consumed by infant | % of mother's own milk (over total enteral nutrition) consumed by infant at 7 days | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal and child health