Metformin to Augment Low Milk Supply (MALMS) Study
MALMS
2 other identifiers
interventional
15
1 country
1
Brief Summary
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
September 1, 2016
2.1 years
June 30, 2014
September 9, 2020
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Change in Milk Output
Maximal change in maternal breast milk production (g/24 hours) between baseline and 4 weeks post-intervention in a model adjusted for baseline milk volume, maternal day postpartum of randomization, and baseline fasting plasma glucose.
baseline and 4 weeks post-intervention
Study Arms (2)
Standard care plus metformin
EXPERIMENTAL67% of stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.
Standard Care plus placebo
PLACEBO COMPARATOR33% of Stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. 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.
Interventions
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).
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)
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.
Eligibility Criteria
You may qualify if:
- Stage 1 Criteria (for participation in baseline measurement phase):
- identified with low milk supply by a Cincinnati-area IBCLC
- mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying (\< 4 times per day), or failure to show any signs of lactogenesis
- mother at least 20 years of age
- infant is between 1 week and 2 calendar months old
- mother gave birth to a single, healthy, term (\>37 weeks gestation) infant
- mother free of breast and nipple infections
- mother lives within study catchment area
- mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during follow up measurements (2-4 weeks) as was consumed during the baseline measurements
- mother not currently taking a prescription medication that may affect the hormones of lactation and not planning to initiate any such drug for at least the next 2-4 weeks.
- mother has established pediatric care for the infant
- successful completion of baseline measurements (involving 24-hour test weighing of milk output and undergoing baseline measurements at the clinical research center, including providing fasting blood samples)
- body mass index is \>19.0 kg/m2 (i.e., not underweight)
- evidence of likely insulin resistance, based on at least one of the following: mean fasting plasma glucose between 95.0 - 125.0 g/dL, inclusive; abdominal obesity; history of polycystic ovary syndrome; or history of gestational diabetes
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Related Publications (5)
Nommsen-Rivers LA, Chantry CJ, Peerson JM, Cohen RJ, Dewey KG. Delayed onset of lactogenesis among first-time mothers is related to maternal obesity and factors associated with ineffective breastfeeding. Am J Clin Nutr. 2010 Sep;92(3):574-84. doi: 10.3945/ajcn.2010.29192. Epub 2010 Jun 23.
PMID: 20573792BACKGROUNDNommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
PMID: 21524193BACKGROUNDLemay DG, Ballard OA, Hughes MA, Morrow AL, Horseman ND, Nommsen-Rivers LA. RNA sequencing of the human milk fat layer transcriptome reveals distinct gene expression profiles at three stages of lactation. PLoS One. 2013 Jul 5;8(7):e67531. doi: 10.1371/journal.pone.0067531. Print 2013.
PMID: 23861770BACKGROUNDWagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.
PMID: 24062375BACKGROUNDNommsen-Rivers L, Thompson A, Riddle S, Ward L, Wagner E, King E. Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial. J Hum Lact. 2019 May;35(2):261-271. doi: 10.1177/0890334418819465. Epub 2019 Jan 10.
PMID: 30629889DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Many mothers wanted to delay enrollment until they could trial non-pharmacologic methods. Many mothers were hesitant to use a medication to try to increase milk supply once seeing how low baseline supply was.
Results Point of Contact
- Title
- Dr. Laurie Nommsen-Rivers
- Organization
- University of Cincinnati
Study Officials
- PRINCIPAL INVESTIGATOR
Laurie A Nommsen-Rivers, PhD
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 2, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2016-09