Nicotinamide Riboside and Milk Production in the NICU

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
View:

• 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

Locations
United States
California
UC Davis Department of Food Science and Technology
RECRUITING
Sacramento
Contact Information
Primary
Bruce German, PhD
jbgerman@ucdavis.edu
(530) 752-1486
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 32
Treatments
Experimental: NR First
Mothers will receive NR during the first 7 days of intervention, then placebo for the 7 days following washout.
Experimental: Placebo First
Mothers will receive placebo during the first 7 days of intervention, then NR for the 7 days following washout.
Related Therapeutic Areas
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov