Using supplements to help increase milk supply in breastfeeding women
Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply
This study is testing whether three different supplements can help breastfeeding women who have low milk supply produce more milk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Winthrop University Academic / other |
| Locations | 1 site (Rock Hill, South Carolina) |
| Trial ID | NCT05398367 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of three different supplements—Oat Mama Lactation Supplement, moringa, and shatavari—on milk production in lactating women experiencing low milk supply. Participants will be randomly assigned to one of four groups, including a placebo group, and will receive weekly support from a lactation consultant. Milk output will be measured at three intervals during the 20-day trial, and blood samples will be collected to analyze serum prolactin levels. The goal is to determine if these supplements can effectively increase milk supply compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are lactating women aged 18 to 39 who are experiencing diagnosed or perceived low milk supply.
Not a fit: Patients with a history of breast reduction or those who have previously used galactagogues during the current lactation cycle may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence-based recommendations for lactating women struggling with low milk supply.
How similar studies have performed: While there have been studies on galactagogues, this specific combination and methodology is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rock Hill, South Carolina
- Winthrop University — Rock Hill, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Hope K Lima, PhD — Winthrop University
- Study coordinator: Hope K Lima, PhD
- Email: limah@winthrop.edu
- Phone: 803-323-4540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.