Moringa Supplementation for Improved Milk Output

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breastfeeding
• Intervention / Treatment: Dietary supplement: Moringa leaf powder; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanna Attia, MD; Phone Number: 859-257-1000; Email: Suzanna.Attia@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moringa; 4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days	Dietary supplement: Moringa leaf powder; capsule ingestion; Other Names: moringa oleifera
Placebo Comparator: Control; comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days	Other: Placebo; capsule ingestion; Other Names: cornstarch

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal milk vitamin A	maternal milk carotenoids	baseline, week 4

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: University of Idaho
• Investigators: Principal Investigator: Suzanna Attia, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: maternal and child health
• Other Study ID Numbers: PED-22-MORINGA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No