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.

چکیده اصلی

INTRODUCTION: An adequate supply of a mother's own milk plays a critical role in optimising health outcomes for at-risk hospitalised infants. Insufficient milk production disproportionately affects the mothers of these infants. In the USA, metoclopramide is the only approved drug available for off-label use as a galactagogue. Nicotinamide riboside (NR), a direct precursor to nicotinamide adenine dinucleotide (NAD+), 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: This double-blind, randomised, placebo-controlled pilot feasibility trial aims to investigate NR supplementation in mothers of infants who are anticipated to be hospitalised in the NICU for at least 4 weeks. We plan to enroll 40 mother-infant pairs with the expectation that 30 will complete the study (n=15 in each group). The intervention period with maternal NR supplementation or placebo supplementation and maternal milk, urine and blood sampling will be 19 days, including an enrollment day.The primary endpoint of the study includes feasibility of enrolling ≥50% of eligible mothers. Secondary endpoints include compliance, adherence or withdrawal from the protocol. Similarly, the study will assess the difference in mean milk volume, macronutrient and micronutrient content, human milk glycans, milk and urine metabolites and infant feeding practice between the two groups. Optional secondary endpoints include differences in serum prolactin, liver function, plasma lipidome, serum metabolites, serum cellular communication network factor 3 concentrations, serum NAD+-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.

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