Summary

Eligibility
for females ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around

Description

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.

Official Title

Nicotinamide Riboside and Milk Production in the NICU

Keywords

Preterm Birth, Inadequate Milk Production, Premature Birth, Niacinamide, Niacin, Nicotinic Acids, Nicotinamide riboside chloride, NR First

Eligibility

You can join if…

Open to females ages 16 years and up

  • 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

You CAN'T join if...

  • 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)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT04614714
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated