Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. The investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (NR) during early postpartum will result in increased milk production. NR is a unique precursor to NAD+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. In lactating rats, NR supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. No studies have been conducted to date that explore the short- or long-term use of NR for increasing milk supply in lactating women. This study will follow a small cohort of women and very preterm infants in the NICU throughout two intervention phases-- one in which each mother will randomly receive either NR or a placebo, then the opposite treatment-- to determine the effect of maternal NR supplementation on expressed milk volume and other markers of metabolism.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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)