A Phase 2/3 interventional study of Nicotinamide Riboside (NR) and Placebo in Preterm Birth and Inadequate Milk Production, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of California, Davis · Phase 2/3, Interventional, and Supportive care
Among 741 studies in Premature Birth with a site in United States — 103 open to participants now, 135 under way, 9 of them phase 3. Premature Birth · United States.
Among the 741 studies in Premature Birth with a site in United States, this one is the 365th largest by planned enrollment of the 528 interventional ones that give a count, is one of 23 that started in 2026, is one of 17 in phase 2/3, reaches primary completion later than 79 of the 134 other live ones, and was the 584th registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
Browse Premature Birth studies →103 of the 741 studies in Premature Birth with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
University of South Carolina · Sites in United States
Columbia University · Sites in United States
University of Alabama at Birmingham · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
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741 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 49 · Phase 2 68 · Phase 3 66 · Phase 4 23
First in 1987; this study’s year is marked. 23 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Median enrollment 86 across the 528 interventional studies, 104 across the 209 observational. Of the 542 that completed or were terminated, 145 (27%) have results posted.
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74 of 741 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 6 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
47 of the studies in Premature Birth with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04614714Phase 3University of California, DavisMilk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants | 2027-08-30 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT01483079Baylor College of MedicinePost-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU) | 2026-12 |
| NCT07060911Neola Medical IncPivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates | 2026-12 |
Among the 741 studies in Premature Birth with a site in United States, from their registry updates:
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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.
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.
Inclusion criteria are required to be met before or at enrollment:
Mothers who are 18 years or older.
Infants delivered at 24-32 weeks OR infants (any GA) that researchers anticipate will be hospitalized in the NICU for at least 4 weeks, including, but not limited to, infants with a diagnosis of gastroschisis, a cardiac defect, intestinal atresia, etc.
Infants born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 7 days of life.
Mothers who attempted initial milk expression within 12 hours of delivery.
Mothers who attempted milk expression at least 6 times every 24 hours from 72 hours after delivery to the Enrollment Visit.
Mothers who have delivered at least 96 hours (4 days) prior to the Enrollment Visit.
Mothers who have experienced a level "3" on the OMPQ before starting the collection of their first 24-hour pooled milk sample (study days 0-3).
Mothers who plan to feed their infants breast milk for at least 3 months.
Mothers who were pregnant with one infant.
Mothers willing to refrain from tandem feeding (directly breastfeeding) another child during the study period.
Mothers willing to refrain from enrolling themselves in another intervention trial during the study period.
Mothers willing to express, weigh, record, and collect 24-hour pooled milk
Mothers willing to remove nipple piercings during the study period.
Mothers willing to refrain from using pseudoephedrine (often found in Sudafed, Theraflu, Claritin-D, etc.) during the study period.
Mothers willing to express milk 6 times or more every 24 hours, including at least once during the night, and with no more than 5 hours between milk expression sessions, during the study period.
Mothers willing to refrain from consuming non-study supplements that contain nicotinamide-riboside (or similar derivatives, including NMN) during the study period.
Mothers willing to refrain from consuming galactagogues during the study period.
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: Nicotinamide Riboside (NR)
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 \[D17-19\].
Other: Placebo
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 \[D17-19\].
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 \[D17-19\].
Feasibility of enrollment in a double-blind placebo-controlled supplementation trial in mothers of infants who are hospitalized.
Proportion of eligible mothers who consent to enrollment in the study.
Time frame: Within 4 days post-delivery of the infant.
Difference in mean milk volume of expressed milk (mL) between NR and placebo
Comparison of total 24-hour expressed breast milk volume (in milliliters) between mothers receiving nicotinamide riboside and those receiving placebo.
Time frame: Volumes will be measured on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in human milk micronutrient concentrations between NR and placebo over time.
Comparison of human milk micronutrient concentrations (Micrograms per liter (µg/L) or milligrams per liter (mg/L), depending on the element) between mothers receiving nicotinamide riboside and those receiving a placebo. Milk samples collected on study days will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) in a certified analytical laboratory.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in amount and diversity of metabolites, including NAD+-related precursors and intermediates in milk between NR and placebo over time.
NMR metabolomics will be used to compare the amount and diversity of metabolites, including NAD⁺-related precursors and intermediates (e.g., nicotinamide riboside, nicotinamide mononucleotide, nicotinamide, NAD⁺) between the NR group and the placebo from the milk samples collected on various study days.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in human milk glycans (HMOs, glycoproteins, glycolipids) between NR and placebo over time.
Comparison of human milk oligosaccharides (HMOs), glycoproteins, and glycolipids in milk samples collected on study days between NR and placebo groups using Nuclear magnetic resonance (NMR) spectroscopy-based metabolomics.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in milk lipidomics in milk between NR and placebo over time.
The difference in milk lipidomics between NR and placebo over time will be measured by Metabolon from samples collected on study days.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in serum prolactin levels at day 18 and the change from the baseline between NR and placebo ( optional participation)
Blood will be collected ( optional participation) on two occasions to look at the difference in serum prolactin levels between the Nicotinamide Riboside supplementation group and the placebo.
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Difference in plasma lipidomics between NR and placebo(optional participation).
Plasma samples will be analyzed using Metabolon's lipodomics platform to assess the effect of nicotinamide riboside ( NR) versus placebo on lipid metabolism. (Optional participation)
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Difference in NAD+-related precursors and intermediates in K2 EDTA whole blood (optional participation) between NR and placebo over time.
The difference in NAD+-related precursors and intermediates in K2 EDTA whole blood will be measured by NADMED between NR and placebo over time.
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Difference in serum metabolites between NR and placebo (optional participation).
Change in Serum NMR metabolites( analyzed by NMR-based metabolomics) will be compared between the nicotinamide riboside and placebo groups.
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Feasibility metrics include supplement compliance, milk sample collection adherence, and withdrawal.
Proportion of enrolled mothers who adhere to the protocol without major deviations.
Time frame: Total Day 18 + 2 days from the day of enrollment [Day 18-20]
Difference in the concentration of CCN3 in milk between NR and placebo over time.
Concentration of CCN3 in milk between NR and placebo over time using quantitative ELISA.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Difference in human milk protein, carbohydrate, and fat concentrations between NR and placebo over time.
Differences in human milk protein, carbohydrate, and fat concentrations will be measured by Miris HMA™between NR and placebo over time.
Time frame: Milk samples will be collected on study Day 0 + 3 days [baseline, pre-intervention], Study Day 10 ± 1 days [mid-intervention], and study Day 17 + 2 days [end of intervention].
Relationship between infant feeding practices and levels of plasma insulin, plasma amino acid, and plasma glucose in infant blood.
Plasma insulin in an infant's blood will be measured from the remnant blood sample in the lab, if any, without having to do an extra blood draw from the infant for the study.
Time frame: Day 1 of life- duration of NICU stay.
Relationship between infant feeding practices and levels of metabolites in infant blood.
The relationship between infant feeding practices will be compared with levels of metabolites measured by NMR metabolomics in infant blood from any remnant blood sample for the infant in the lab, without having to do an additional blood draw for the study.
Time frame: Day 1 of life to the duration of NICU stay.
Feasibility of supplement compliance and milk sample collection adherence, and withdrawal from the study
Proportion of enrolled mothers who adhere to the protocol without major deviations.
Time frame: Study start to end of study
Difference in maternal serum CCN3 between NR and placebo (Optional Participation)
Difference in maternal serum CCN3 between NR and placebo at baseline and Day 18.
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Change in maternal weight (lbs.)
This exploratory outcome measures change in maternal weight from baseline to the end of the study in participants receiving nicotinamide riboside versus placebo, measured using a calibrated digital scale at each study visit.
Time frame: Study Day 3 ± 1 days [randomization, pre-intervention visit] and Study Day 18 + 2 days [end of study visit]
Outcome of growth parameters: Infant length (cm), weight(g), and head circumference ( cm).
This exploratory outcomes measure the changes in growth parameters (height, weight, and head circumference) using calculated z-scores (as measured by standard deviations from the mean, presented in percentages relative to the average for age).
Time frame: Day 1 - Day 28
NICU outcomes
NICU outcomes accessible in the EMR include morbidity, death, necrotizing enterocolitis, chronic lung disease, retinopathy of prematurity, and sepsis.
Time frame: Day 1 of life - end of NICU visit.
Difference in the concentration of urinary metabolites, including NAD+-specific metabolites as a proxy of NR supplementation, between NR and placebo over time.
Urinary metabolites will be measured using nuclear magnetic resonance (NMR)-based metabolomics between the nicotinamide riboside (NR) and placebo groups.
Time frame: Urine samples will be collected on two occasions, Study Day 3 ± 1 days [Randomization visit] and Study Day 18 + 2 days [End of study visit ]
Difference in serum biomarkers of liver function and calcium between NR and placebo (optional participation).
Differences in serum biomarkers of liver function (AST/ALT) and calcium will be measured via a CMP between NR and placebo.
Time frame: Study Day 3 + 1/-3 days [baseline] and Study Day 18 + 2/-1 days [end of study visit]
Diet, health, and anthropometric outcomes reported by mothers when their child turns 1, 2, and 3 years of age.
These will be obtained as a complete three-brief (10-15 minute) phone interviews when their child turns 1, 2, and 3 years old. Each call, conducted by study personnel after the child's annual well-child visit, will include a semi-structured survey about the child's diet, general health, and growth (weight, height, etc.). Participants will receive a $25 Amazon e-gift card for each completed interview (up to $75 total). Mothers may choose to complete one, two, or all three interviews.
Time frame: Day 1 of life to 3 years of age for the child.
Plan to share: Undecided
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
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