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OpenTrials
Completed

NCT Number: NCT05333939

Moringa Supplementation for Improved Milk Output

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

0 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moringa leaf powder

Dietary Supplement

capsule ingestion

Other names: moringa oleifera

Placebo

Other

capsule ingestion

Other names: cornstarch

Primary outcomes

  1. Milk output

    Time frame: 7 days

    24 hour milk output at 7 days

Secondary outcomes

  1. % 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

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • University of Idaho

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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