Galactagogue Use in Lactating Women With Low Milk Supply

Part of paid clinical trials in Rock Hill, South Carolina.

Sponsor
Winthrop University
Study ID
NCT05398367
Status
Recruiting

Conditions

  • Breast Milk Expression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Galactagogue Supplement for Treatment of Low Milk Supply — DIETARY_SUPPLEMENT
    Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply

Study Details

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.

Key Dates

Start date
Mar 5, 2024
Status verified
Mar 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oat Mama Lactation Supplement
    Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions
  • Experimental: Moringa Supplement
    Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions
  • Experimental: Shatavari Supplement
    Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions
  • Placebo Comparator: Placebo
    Participants will receive a 20 day supply of placebo pills containing a mixture of flour and brown sugar. Participants will consume 2 placebo pills once per day for 20 days.

Primary Outcome Measure

Change in Breast Milk Supply [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Winthrop UniversityRock HillSouth Carolina29733
Hope K Lima, PhD
803-323-4540
Hope K Lima, PhD (PRINCIPAL_INVESTIGATOR)

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