Moringa Supplementation for Improved Milk Output

October 15, 2024 updated by: Suzanna L Attia, University of Kentucky

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 7 days
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
Time Frame: 7 days
% 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
Time Frame: baseline, week 4
maternal milk carotenoids
baseline, week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Collaborators

University of Idaho

Investigators

  • Principal Investigator: Suzanna Attia, MD, University of Kentucky

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 Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

August 3, 2024

Study Completion (Actual)

August 3, 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)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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