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Galactagogue Use in Lactating Women With Low Milk Supply

Primary Purpose

Breast Milk Expression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Galactagogue Supplement for Treatment of Low Milk Supply
Sponsored by
Winthrop University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Milk Expression

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Winthrop UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Oat Mama Lactation Supplement

Moringa Supplement

Shatavari Supplement

Placebo

Arm Description

Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions

Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions

Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions

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.

Outcomes

Primary Outcome Measures

Change in Breast Milk Supply
Change in breast milk supply will be evaluated using 24-hour breast milk expression volume
Change in Serum Prolactin
Change in serum prolactin levels will be evaluated by taking blood samples on day 1, 10, and 20 and measuring serum prolactin using a human serum prolactin ELISA kit

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
April 24, 2023
Sponsor
Winthrop University
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1. Study Identification

Unique Protocol Identification Number
NCT05398367
Brief Title
Galactagogue Use in Lactating Women With Low Milk Supply
Official Title
Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Winthrop University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk Expression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C).
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind randomized controlled trial
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oat Mama Lactation Supplement
Arm Type
Experimental
Arm Description
Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions
Arm Title
Moringa Supplement
Arm Type
Experimental
Arm Description
Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions
Arm Title
Shatavari Supplement
Arm Type
Experimental
Arm Description
Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Galactagogue Supplement for Treatment of Low Milk Supply
Intervention Description
Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
Primary Outcome Measure Information:
Title
Change in Breast Milk Supply
Description
Change in breast milk supply will be evaluated using 24-hour breast milk expression volume
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
Title
Change in Serum Prolactin
Description
Change in serum prolactin levels will be evaluated by taking blood samples on day 1, 10, and 20 and measuring serum prolactin using a human serum prolactin ELISA kit
Time Frame
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Lactating women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hope K Lima, PhD
Phone
803-323-4540
Email
limah@winthrop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hope K Lima, PhD
Organizational Affiliation
Winthrop University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29733
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hope K Lima, PhD
Phone
803-323-4540
Email
limah@winthrop.edu
First Name & Middle Initial & Last Name & Degree
Hope K Lima, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There will be no sharing of individual participant data to researchers outside of the experimental team.

Learn more about this trial

Galactagogue Use in Lactating Women With Low Milk Supply

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