NCT04614714

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

Nicotinamide Riboside and Milk Production in the NICU

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

An adequate supply of a mother's own milk plays a critical role in optimizing health outcomes for at-risk infants, such as preterm and medically or surgically complex term infants. Despite this, insufficient milk production disproportionately affects the mothers of these infants. In the United States, metoclopramide is the only drug approved by the FDA for off-label use as a galactagogue. Nicotinamide riboside (NR), a niacin precursor, has been shown in a murine model to support lean body composition in lactating dams while augmenting high-quality milk production and enhancing cognitive and physical development of pups. Human testing with NR has been limited to long-term safety and bioavailability measures. This study aims to assess the feasibility of NR supplementation in mothers whose infants are admitted to the NICU for at least 4 weeks. To address this gap, this study will enroll a small cohort of mothers with infants, either born preterm (\<32 weeks of gestation) or term infants with complex medical or surgical conditions, admitted to the NICU for at least four weeks. This double-blinded, randomized, placebo-controlled pilot feasibility trial aims to investigate NR supplementation in mothers of infants who are hospitalized in the NICU for at least 4 weeks. The intervention period with maternal nicotinamide riboside supplementation/placebo and maternal milk, urine, and blood sampling will be 19 days, including an enrollment day. We aim to establish the feasibility of conducting a supplementation study in mothers of hospitalized infants, with enrollment feasibility defined as enrolling ≥ 50% eligible mothers. Secondary objectives include assessing feasibility metrics (supplement compliance, milk sample collection adherence, and withdrawal rates); protocol adherence; and the impact of nicotinamide riboside supplementation on milk volume, milk composition (including macro- and micronutrient composition, glycans, metabolites, lipidomics, and CCN3), and urinary metabolites. Remnant infant blood samples will be used to examine the relationship between infant feeding practices and neonatal insulin, glucose, and amino acid concentrations. An optional component of the study is the collection of maternal blood to assess the impact of NR supplementation on the concentration of serum prolactin, AST, ALT, metabolites, and CCN3; plasma lipidomics; and whole blood concentration of NAD+ related precursors.

Conditions

• Preterm Birth
• Inadequate Milk Production

Interventions

Type	Name	Description
OTHER	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 \[D17-19\].
OTHER	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 \[D17-19\].

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-11-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States