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

NCT04614714 | Not Yet Recruiting Phase 2

• 1 other identifier: 1557473
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Inadequate Milk Production

Keywords

Nicotinamide Riboside; milk volume; Neonatal intensive care unit; Galactagogue; Feasibility trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 4 days post-delivery of the infant.

Secondary Outcomes (16)

• Difference in mean milk volume of expressed milk (mL) between NR and placebo

  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.

  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.

  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.

  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.

  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].

Other Outcomes (6)

• Change in maternal weight (lbs.)

  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).

  Day 1 - Day 28

• NICU outcomes

  Day 1 of life - end of NICU visit.

Study Arms (2)

Nicotinamide Riboside (NR)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Nicotinamide Riboside (NR) OTHER

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 \[D17-19\].

Nicotinamide Riboside (NR)

Placebo OTHER

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 \[D17-19\].

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• ChromaDex, Inc.: collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (19)

• Yang D, Wan Y. NR Supplementation During Lactation: Benefiting Mother and Child. Trends Endocrinol Metab. 2019 Apr;30(4):225-227. doi: 10.1016/j.tem.2019.02.004. Epub 2019 Feb 21.

  PMID: 30797625 RESULT

• Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7.

  PMID: 29599478 RESULT

• Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.

  PMID: 29992272 RESULT

• Damgaard MV, Treebak JT. What is really known about the effects of nicotinamide riboside supplementation in humans. Sci Adv. 2023 Jul 21;9(29):eadi4862. doi: 10.1126/sciadv.adi4862. Epub 2023 Jul 21.

  PMID: 37478182 RESULT

• Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.

  PMID: 27721479 RESULT

• Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.

  PMID: 31278280 RESULT

• Ear PH, Chadda A, Gumusoglu SB, Schmidt MS, Vogeler S, Malicoat J, Kadel J, Moore MM, Migaud ME, Stevens HE, Brenner C. Maternal Nicotinamide Riboside Enhances Postpartum Weight Loss, Juvenile Offspring Development, and Neurogenesis of Adult Offspring. Cell Rep. 2019 Jan 22;26(4):969-983.e4. doi: 10.1016/j.celrep.2019.01.007.

  PMID: 30673618 RESULT

• Moller L, Crone KL, Mortensen N. [Brucellosis: 3 imported cases]. Ugeskr Laeger. 1985 Jul 1;147(27):2164-6. No abstract available. Danish.

  PMID: 4060272 RESULT

• Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

  PMID: 32421208 RESULT

• Shen Q, Khan KS, Du MC, Du WW, Ouyang YQ. Efficacy and Safety of Domperidone and Metoclopramide in Breastfeeding: A Systematic Review and Meta-Analysis. Breastfeed Med. 2021 Jul;16(7):516-529. doi: 10.1089/bfm.2020.0360. Epub 2021 Mar 25.

  PMID: 33769844 RESULT

• Hussain NHN, Noor NM, Ismail SB, Zainuddin NA, Sulaiman Z. Metoclopramide for Milk Production in Lactating Women: A Systematic Review and Meta-Analysis. Korean J Fam Med. 2021 Nov;42(6):453-463. doi: 10.4082/kjfm.20.0238. Epub 2021 Nov 20.

  PMID: 34871486 RESULT

• Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Caddell K, Allen VM, Dooley KC. Effect of domperidone on the composition of preterm human breast milk. Pediatrics. 2010 Jan;125(1):e107-14. doi: 10.1542/peds.2008-3441. Epub 2009 Dec 14.

  PMID: 20008425 RESULT

• Grzeskowiak LE, Smithers LG, Amir LH, Grivell RM. Domperidone for increasing breast milk volume in mothers expressing breast milk for their preterm infants: a systematic review and meta-analysis. BJOG. 2018 Oct;125(11):1371-1378. doi: 10.1111/1471-0528.15177. Epub 2018 Mar 27.

  PMID: 29469929 RESULT

• Grzeskowiak LE, Wlodek ME, Geddes DT. What Evidence Do We Have for Pharmaceutical Galactagogues in the Treatment of Lactation Insufficiency?-A Narrative Review. Nutrients. 2019 Apr 28;11(5):974. doi: 10.3390/nu11050974.

  PMID: 31035376 RESULT

• Kwan SH, Abdul-Rahman PS. Clinical Study on Plant Galactagogue Worldwide in Promoting Women's Lactation: a Scoping Review. Plant Foods Hum Nutr. 2021 Sep;76(3):257-269. doi: 10.1007/s11130-021-00901-y. Epub 2021 Jul 22.

  PMID: 34292494 RESULT

• Zukova S, Krumina V, Buceniece J. Breastfeeding preterm born infant: Chance and challenge. Int J Pediatr Adolesc Med. 2021 Jun;8(2):94-97. doi: 10.1016/j.ijpam.2020.02.003. Epub 2020 Feb 6.

  PMID: 34084879 RESULT

• https://doi.org/10.1542/peds.2008-3441

  RESULT

• https://www.nadmed.com/wp-content/uploads/2025/03/RUO_Qualio-IFU-NAD-and-NADH-blood-v8.0-1.pdf

  RESULT

• Babey ME, Krause WC, Chen K, Herber CB, Torok Z, Nikkanen J, Rodriguez R, Zhang X, Castro-Navarro F, Wang Y, Wheeler EE, Villeda S, Leach JK, Lane NE, Scheller EL, Chan CKF, Ambrosi TH, Ingraham HA. A maternal brain hormone that builds bone. Nature. 2024 Aug;632(8024):357-365. doi: 10.1038/s41586-024-07634-3. Epub 2024 Jul 10.

  PMID: 38987585 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Nicole Cacho, DO

CONTACT

916-619-6081; ntcacho@ucdavis.edu

Kara Kuhn Riordon, MD

CONTACT

916-619-6081; kmkuhn@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)