Status:

COMPLETED

Moringa Supplementation for Improved Milk Output

Lead Sponsor:

University of Kentucky

Collaborating Sponsors:

University of Idaho

Conditions:

Breastfeeding

Eligibility:

All Genders

Phase:

NA

Brief 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 q...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 17 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 3 2024

    Estimated Enrollment :

    41 Patients enrolled

    Trial Details

    Trial ID

    NCT05333939

    Start Date

    May 17 2022

    End Date

    August 3 2024

    Last Update

    October 17 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Kentucky

    Lexington, Kentucky, United States, 40506