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

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test NAD+.

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.

It had two arms (groups): Nicotinamide Riboside (NR) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as other.

More on the Plan

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.

Human testing with NR has been limited to long-term safety and bioavailability measures.

Who Took Part

40 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

The NAD+ group and the comparison group ran side by side rather than switching.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2026-08-19 with completion listed for 2027-08-30.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 16 secondary outcomes, for example Difference in mean milk volume of expressed milk (mL) between NR and placebo, Difference in human milk micronutrient concentrations between NR and placebo over time, Difference in human milk glycans (HMOs, glycoproteins, glycolipids) between NR and placebo over time, Difference in milk lipidomics in milk between NR and placebo over time, Difference in serum prolactin levels at day 18 and the change from the baseline between NR and placebo ( optional participation) and Difference in plasma lipidomics between NR and placebo(optional participation).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of NAD+ in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.