Moringa Supplementation for Improved Milk Output

NCT ID: NCT05333939

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2024-08-03

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.

Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo controlled randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Moringa

4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days

Group Type EXPERIMENTAL

Moringa leaf powder

Intervention Type DIETARY_SUPPLEMENT

capsule ingestion

Control

comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

capsule ingestion

Interventions

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Moringa leaf powder

capsule ingestion

Intervention Type DIETARY_SUPPLEMENT

Placebo

capsule ingestion

Intervention Type OTHER

Other Intervention Names

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moringa oleifera cornstarch

Eligibility Criteria

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Inclusion Criteria

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:

ยท any condition where breastmilk is clinically contraindicated
Minimum Eligible Age

0 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Idaho

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Suzanna L Attia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanna Attia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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PED-22-MORINGA

Identifier Type: -

Identifier Source: org_study_id

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