Metformin to Augment Low Milk Supply (MALMS) Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Low Milk SupplyPre-diabetesInsulin ResistanceSuppressed Lactation
Interventions
BEHAVIORAL

Standard care

Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump (provided by study).

DRUG

Metformin

"The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~* Days 1-7, take one 750 mg capsule with evening meal (750 mg/day)~* Days 8-14, take three 500 mg capsule with evening meal (1500 mg/day)~* Days 14-28 (or through completion of post-intervention data collection), take four 500 mg capsules with evening meal (2000 mg/day)~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator.~The trial duration is 28 days (with a +/- 3 day cushion)"

DRUG

Placebo

"The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule:~* Days 1-7, take 1 capsule with evening meal~* Days 8-14, take 3 capsules with evening meal~* Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator."

Trial Locations (1)

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

University of Cincinnati

OTHER

lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT02179788 - Metformin to Augment Low Milk Supply (MALMS) Study | Biotech Hunter | Biotech Hunter