Clinical trial NCT04614714: Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
Official title: Nicotinamide Riboside and Milk Production in the NICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Preterm Birth
Inadequate Milk Production
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Difference in mean milk volume of expressed milk (mL) between NR and placebo
timeFrame: Day 2 - Day 10
Secondary outcomes:
measure: Difference in mean milk volume of expressed milk (mL) between NR and placebo
timeFrame: Day 2 - Days 7, 12, 17, and 20
measure: Difference in change in mean milk volume between baseline and each time point (mL) between NR and placebo
timeFrame: Day 2 - Days 7 and 10; Day 12 - Days 17 and 20
measure: Difference in serum prolactin levels and the difference between NR and placebo
timeFrame: Day 2 - Day 10
measure: Concentration of fat, protein, and carbohydrates in expressed milk (g/100 mL)
timeFrame: Day 2 - Day 20
measure: Concentration of metabolite species in maternal urine (μM) between NR and placebo
timeFrame: Day 2 - Day 20
measure: Difference in mean size of milk fat globule (μm) between NR and placebo
timeFrame: Day 10 - Day 20
measure: Average PC/PE ratio of milk fat globule membrane
timeFrame: Day 10 - Day 20
measure: Oligosaccharide content of expressed milk
timeFrame: Day 2 - Day 20
measure: Infant fecal microbiota
timeFrame: Day 2 - Day 20
measure: Concentration of BDNF in expressed milk (pg/mL)
timeFrame: Day 2 - Day 20
Other outcomes:
measure: Change in maternal weight (lbs.)
timeFrame: Day 2 - Day 20
measure: Infant length (cm)
timeFrame: Day 1 - Day 28
measure: Infant weight (g)
timeFrame: Day 1 - Day 28
measure: Infant head circumference (cm)
timeFrame: Day 1 - Day 28
measure: NICU outcomes
timeFrame: Day 1 - Day 28
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Food Science and Technology
state: California
Study officials:
affiliation: UC Davis
name: Kara Khun-Riordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Nicole Cacho, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Luna Khanal, MD
role: PRINCIPAL_INVESTIGATOR
References: