Recruiting
Phase 2
Phase 3

Nicotinamide Riboside

Sponsor:

UCLA

Code:

NCT04614714

Conditions

Preterm Birth

Inadequate Milk Production

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nicotinamide Riboside (NR)

Placebo

Study Details

Brief summary:

This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.

Conditions

Preterm Birth

Inadequate Milk Production

Study ID

NCT04614714

Start date

Aug 19, 2026

Status verified date

Sep, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria are required to be met before or at enrollment:

Mothers who are 18 years or older.

Infants delivered at 24-32 weeks OR infants (any GA) that researchers anticipate will be hospitalized in the NICU for at least 4 weeks, including, but not limited to, infants with a diagnosis of gastroschisis, a cardiac defect, intestinal atresia, etc.

Infants born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 7 days of life.

Mothers who attempted initial milk expression within 12 hours of delivery.

Mothers who attempted milk expression at least 6 times every 24 hours from 72 hours after delivery to the Enrollment Visit.

Mothers who have delivered at least 96 hours (4 days) prior to the Enrollment Visit.

Mothers who have experienced a level "3" on the OMPQ before starting the collection of their first 24-hour pooled milk sample (study days 0-3).

Mothers who plan to feed their infants breast milk for at least 3 months.

Mothers who were pregnant with one infant.

Mothers willing to refrain from tandem feeding (directly breastfeeding) another child during the study period.

Mothers willing to refrain from enrolling themselves in another intervention trial during the study period.

Mothers willing to express, weigh, record, and collect 24-hour pooled milk

Mothers willing to remove nipple piercings during the study period.

Mothers willing to refrain from using pseudoephedrine (often found in Sudafed, Theraflu, Claritin-D, etc.) during the study period.

Mothers willing to express milk 6 times or more every 24 hours, including at least once during the night, and with no more than 5 hours between milk expression sessions, during the study period.

Mothers willing to refrain from consuming non-study supplements that contain nicotinamide-riboside (or similar derivatives, including NMN) during the study period.

Mothers willing to refrain from consuming galactagogues during the study period.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nicotinamide Riboside (NR)

Mothers receive daily oral nicotinamide riboside chloride 250 mg supplementation per day for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].

placebo comparator: Placebo

Mothers receive a daily oral placebo, microcrystalline cellulose 250 mg per day matched in appearance and schedule to the nicotinamide riboside supplement for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].

Interventions

Nicotinamide Riboside (NR)

Mothers receive daily oral nicotinamide riboside chloride 250 mg supplementation per day for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].

Placebo

Mothers receive a daily oral placebo, microcrystalline cellulose 250 mg per day matched in appearance and schedule to the nicotinamide riboside supplement for 14 days (+ 2 days extra capsule for loss or extending sample collection), from study Day 4 + 1 day \[D4-5\] to study Day 17 + 2 days \[D17-19\].

Primary outcome measure

  • Feasibility of enrollment in a double-blind placebo-controlled supplementation trial in mothers of infants who are hospitalized. [ Time Frame: Within 4 days post-delivery of the infant. ]

Central Contacts and Locations

Central contacts

Nicole Cacho, DO

916-619-6081ntcacho@ucdavis.edu

Kara Kuhn Riordon, MD

916-619-6081kmkuhn@ucdavis.edu

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

More Information

Sponsor

University of California, Davis

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Nicotinamide Riboside
  • milk volume
  • Neonatal intensive care unit
  • Galactagogue
  • Feasibility trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-09-14.