Galactagogue Use in Lactating Women with Low Milk Supply

Last updated: March 24, 2025
Sponsor: Winthrop University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Galactagogue Supplement for Treatment of Low Milk Supply

Clinical Study ID

NCT05398367
IRB22107R
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study aims to determine whether a 20-day supplement with either Oat Mama Lactation Supplement, moringa, or shatavari has any impact on milk production through an increase in serum prolactin levels when compared to the placebo group. This data will be used to determine if clinical recommendations can be made for the use of the studied supplements in increasing milk supply.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants in the study must:

  • Be struggling with diagnosed or perceived low milk supply

  • Be willing to consume a randomly assigned galactagogue or placebo supplement

  • Be willing to provide a blood sample at each lactation consult (day 1, 10, 20)

  • Be willing to provide 24-hour expressed milk volume either using pre- and post-feedweights, total pump output, or a combination of both on day 1, 10, and 20

Exclusion

Exclusion Criteria: Participants will be excluded if:

  • They have a history of breast reduction

  • They have a history of utilizing in vitro fertilization

  • They are not a biological female with mammary glands present for producing milk

  • They have consumed galactagogues with the intention of increasing their milk supplyduring the current lactation cycle

  • They are under age 18 or above age 39

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Galactagogue Supplement for Treatment of Low Milk Supply
Phase:
Study Start date:
March 05, 2024
Estimated Completion Date:
June 01, 2026

Study Description

This study will be a double-blind randomized control trial where eligible participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C). All participants will receive a supplement or placebo for consumption throughout the 20-day trial period, and all participants will receive support from a lactation consultant once per week to receive appropriate guidance for increasing milk supply. 24-hour milk output will be recorded on day 1, 10, and 20 using either pre- and post-feeding weights, 24-hour pump output, or a combination of both. Additionally, blood samples will be taken on day 1, 10, and 20 and serum will be isolated for later analysis of serum prolactin levels.

Connect with a study center

  • Winthrop University

    Rock Hill, South Carolina 29733
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.