Galactagogue Use in Lactating Women With Low Milk Supply
ConditionBreast Milk Expression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorWinthrop University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Galactagogue Supplement for Treatment of Low Milk Supply
Dietary supplementParticipants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Oat Mama Lactation SupplementExperimental treatment 1 intervention
Group B: Moringa SupplementExperimental treatment 1 intervention
Group C: Shatavari SupplementExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Breast Milk Supply
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 period2
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
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 kitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov