Moringa Supplementation for Improved Milk Output

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Breastfeeding

🗓️ Study Start (Actual) 17 May 2022

🗓️ Primary Completion (Estimated) May 2025

✅ Study Completion (Estimated) May 2025

👥 Enrollment (Estimated) 60

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Lexington, Kentucky, United States

📋 Eligibility Criteria

Description

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: 0 Months to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 28 March 2022
First Submitted that Met QC Criteria 11 April 2022
First Posted 19 April 2022

Study Record Updates