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

Preterm Birth Clinical Trial

— MOONRISE  

Official title:

Nicotinamide Riboside and Milk Production in the NICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04614714
• Other study ID #: 1557473
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: Bruce German, PhD
• Phone: (530) 752-1486
• Email: jbgerman[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inadequate Milk Production
• Premature Birth
• Preterm Birth

Intervention

Drug:
• Nicotinamide riboside chloride
Nicotinamide riboside chloride 250 mg capsules, administered once per day (Day 1-7 or Day 11-17)
• Placebo
Maltodextrin placebo, administered once per day (Day 1-7 or Day 11-17)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in maternal weight (lbs.)		Day 2 - Day 20
Other	Infant length (cm)		Day 1 - Day 28
Other	Infant weight (g)		Day 1 - Day 28
Other	Infant head circumference (cm)		Day 1 - Day 28
Other	NICU outcomes	Including morbidity, death, necrotizing enterocolitis, chronic lung disease, sepsis, etc.	Day 1 - Day 28
Primary	Difference in mean milk volume of expressed milk (mL) between NR and placebo	Measured by 24-hour expressions	Day 2 - Day 10
Secondary	Difference in mean milk volume of expressed milk (mL) between NR and placebo	Measured by 24-hour expressions	Day 2 - Days 7, 12, 17, and 20
Secondary	Difference in change in mean milk volume between baseline and each time point (mL) between NR and placebo	Measured by 24-hour expressions	Day 2 - Days 7 and 10; Day 12 - Days 17 and 20
Secondary	Difference in serum prolactin levels and the difference between NR and placebo	Taken at two time points	Day 2 - Day 10
Secondary	Concentration of fat, protein, and carbohydrates in expressed milk (g/100 mL)		Day 2 - Day 20
Secondary	Concentration of metabolite species in maternal urine (µM) between NR and placebo		Day 2 - Day 20
Secondary	Difference in mean size of milk fat globule (µm) between NR and placebo		Day 10 - Day 20
Secondary	Average PC/PE ratio of milk fat globule membrane		Day 10 - Day 20
Secondary	Oligosaccharide content of expressed milk	Measured as relative abundance (%)	Day 2 - Day 20
Secondary	Infant fecal microbiota	Measured as relative abundance (%)	Day 2 - Day 20
Secondary	Concentration of BDNF in expressed milk (pg/mL)		Day 2 - Day 20