RecruitingNot Applicable

Galactagogue Use in Lactating Women With Low Milk Supply

United States120 participantsStarted 2024-03-05

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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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-feed weights, total pump output, or a combination of both on day 1, 10, and 20 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 supply during the current lactation cycle * They are under age 18 or above age 39

What they're measuring

Change in Breast Milk Supply

Timeframe: Intervention will last 20 days and 24-hour breast milk expression volume will be measured on day 1, 10, and 20 and used to calculate change in 24-hour breast milk expression volume over the trial period

Change in Serum Prolactin

Timeframe: Intervention will last 20 days and blood samples will be taken on day 1, 10, am 20 and change in serum prolactin will be measured using a human serum prolactin ELISA kit

Trial details

NCT IDNCT05398367

SponsorWinthrop University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

Contact for this trial

Hope K Lima, PhD

803-323-4540 limah@winthrop.edu

View on ClinicalTrials.gov More Breast Milk Expression trials