Increasing milk production in mothers of extremely preterm infants using a supplement
Nicotinamide Riboside and Milk Production in the NICU
This study is testing if a supplement called nicotinamide riboside can help mothers of extremely preterm infants produce more breast milk.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04614714 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of nicotinamide riboside (NR) supplementation on milk production in mothers of extremely preterm infants. The researchers hypothesize that NR, a precursor to NAD+, can enhance metabolic processes that support lactation. Mothers will be randomly assigned to receive either NR or a placebo during the early postpartum period, and their milk volume will be measured. The study aims to provide insights into the potential benefits of NR for improving breastfeeding outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers who have delivered infants at or before 28 weeks gestation and are willing to participate in milk volume measurement.
Not a fit: Patients who may not benefit include those with a history of breast surgery, those using certain medications, or those who do not reside within 50 miles of the UC Davis Medical Center.
Why it matters
Potential benefit: If successful, this study could significantly improve milk production in mothers of preterm infants, enhancing the nutritional support for their babies.
How similar studies have performed: While no studies have specifically tested NR for increasing milk supply in lactating women, previous research in lactating rats has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent for participation of both mother and baby * infant delivered at ≤28 weeks gestation * Infant born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 6 days of life. * Mothers willing to express and measure milk volume Exclusion Criteria: * Infant is participating in an intervention trial that could influence growth, development, or feeding tolerance * Mother has previously undergone breast surgery or has experienced other breast trauma * Mother is actively using narcotics or amphetamines * Mothers is receiving cancer treatment * Mothers is receiving lithium or gold therapies * Mother plans to use any form of galactagogue (including fenugreek) * Mother is taking any form of contraceptives or plans to resume use of contraceptive within four weeks of delivery * Mother is involuntarily confined * Mother is an adult unable to consent * Mother resides \<50 miles from UC Davis Medical Center * Anyone deemed unfit for participation by investigator(s)
Where this trial is running
Sacramento, California
- UC Davis Department of Food Science and Technology — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Bruce German, PhD
- Email: jbgerman@ucdavis.edu
- Phone: (530) 752-1486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.