Moringa Supplementation for Improved Milk Output

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333939
• Other study ID #: PED-22-MORINGA
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Suzanna Attia, MD
• Phone: 859-257-1000
• Email: Suzanna.Attia[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Dietary Supplement:
• Moringa leaf powder
capsule ingestion

Other:
• Placebo
capsule ingestion

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	University of Idaho

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Milk output	24 hour milk output at 7 days	7 days
Secondary	% mother's own milk consumed by infant	% of mother's own milk (over total enteral nutrition) consumed by infant at 7 days	7 days