---
title: "Nicotinamide riboside for increasing milk production in NICU mothers: MOONRISE pilot protocol"
id: "bmj-open-6-does-nicotinamide-riboside-supplementation-increase-milk-production-in"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-6-does-nicotinamide-riboside-supplementation-increase-milk-production-in"
content_type: "clinical_feed_article"
specialty: "Pediatrics"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/10/e118516?rss=1"
published_at: "2026-10-07T11:48:05.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Nicotinamide riboside for increasing milk production in NICU mothers: MOONRISE pilot protocol
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-6-does-nicotinamide-riboside-supplementation-increase-milk-production-in
- **Specialty:** [Pediatrics](https://medichelpline.com/clinical-feed/pediatrics.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/10/e118516?rss=1)
- **Published At:** 2026-10-07T11:48:05.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The MOONRISE trial is a double-blind, randomised, placebo-controlled pilot feasibility study testing **nicotinamide riboside (NR)** supplementation in mothers whose infants are expected to remain in the neonatal intensive care unit (**NICU**) for at least 4 weeks. - The rationale: adequate supply of a mother’s own milk is critical for at-risk hospitalised infants, yet insufficient milk production disproportionately affects mothers of NICU infants. Preclinical murine data suggested NR, a precursor to **NAD+**, can augment high-quality milk production and improve pup outcomes; human lactation studies with NR have not been done. - Design: enroll 40 mother–infant pairs with an expected completion of 30 pairs (approximately 15 per arm). The intervention and sampling window is 19 days including enrollment. - Primary feasibility endpoint: ability to enrol ≥50% of eligible mothers. Secondary feasibility outcomes: compliance, adherence and withdrawal rates. - Biological and clinical secondary endpoints: difference in mean milk volume; milk macronutrient and micronutrient composition; human milk glycans; milk and urine metabolites; infant feeding practices. Optional secondary laboratory endpoints include serum prolactin, liver function tests, plasma lipidome, serum metabolites, serum CCN3 (cellular communication network factor 3), and NAD+-related precursors and intermediates. - Exploratory outcomes: maternal weight change, infant developmental measures and NICU clinical outcomes. Safety endpoints include frequency of adverse events. - Ethics and oversight: IRB approval at University of California Davis Medical Center (protocol version date 1 June 2026; approval number 1557473). Results will be communicated via peer-reviewed publications, conference presentations, ClinicalTrials.gov reporting and PubMed Central. Deidentified participant data will be available to qualified researchers after publication subject to approvals and a data use agreement. - Trial registration: ClinicalTrials.gov NCT04614714. - Key limitations of this protocol report: it is a pilot feasibility trial and not powered for definitive efficacy; specifics of NR dosing, exact laboratory assays, and detailed statistical plans were not reported in the source summary.
## Clinical Analysis & Structured Key Points
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 .
## Related Clinical Research

- [Barriers to Adolescent Pregnancy Prevention in LMICs: Implementers’ Perspectives](https://medichelpline.com/clinical-feed/plos-one-23-exploring-barriers-to-implementing-adolescent-pregnancy-prevention.md)
- [Correction: Parental intestinal microbiome study — author name updated](https://medichelpline.com/clinical-feed/plos-one-2-correction-the-parental-intestinal-microbiome-modulates-systemic-and-local.md)
- [Minimally-processed cow's milk and early-childhood asthma outcomes — MARTHA randomized trial](https://medichelpline.com/clinical-feed/medrxiv-4-minimally-processed-cow-s-milk-and-early-childhood-asthma-related-outcomes.md)
- [ReDiKid national cohort protocol: longitudinal trajectories of child resilience and risk exposures](https://medichelpline.com/clinical-feed/medrxiv-3-developmental-trajectories-of-child-resilience-their-determinants-and.md)
- [Spatial profiling links STING to Kawasaki disease cardiac inflammation](https://medichelpline.com/clinical-feed/biorxiv-2-spatial-profiling-of-kawasaki-disease-cardiac-inflammation-identifies-sting-as.md)

## Navigation
- [← Back to Pediatrics Feed](https://medichelpline.com/clinical-feed/pediatrics.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.