Does nicotinamide riboside supplementation increase milk production in postpartum women with infants admitted to a neonatal intensive care unit? Protocol for the MOONRISE randomised, double-blind, placebo-controlled pilot feasibility trial.

INTRODUCTION: ), has been shown in a murine model to augment high-quality milk production and enhance cognitive and physical development of pups. Human testing with NR has been limited, and studies in lactating individuals have not been performed. The aim of this study is to assess the feasibility of NR supplementation in mothers whose infants are admitted to the neonatal intensive care unit (NICU) for at least 4 weeks. METHOD AND ANALYSIS: -related precursors and intermediates between mothers of the two groups. Exploratory outcomes include changes in mothers' weight and infants' developmental and NICU outcomes. Safety endpoints include the frequency of adverse events. ETHICS AND DISSEMINATION: The Institutional Review Board (IRB) protocol version date is 1 June 2026, approved by the IRB at the University of California Davis Medical Center (approval number: 1557473). Study investigators will communicate trial results to participants, healthcare professionals and the public through peer-reviewed publications and presentations at scientific conferences. Trial results will also be reported on ClinicalTrials.gov and made available through PubMed Central, in accordance with regulatory requirements. Deidentified participant data will be available to qualified researchers upon request after publication. Approved requests will be granted access within 12 months and are subject to study team and IRB approval and a data use agreement. TRIAL REGISTRATION NUMBER: NCT04614714.