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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04614714
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Inadequate Milk Production
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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 \[D17-19\].
  • 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 \[D17-19\].

Study Details

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.

Key Dates

First listed
Nov 4, 2020
Start date
Aug 19, 2026
Status verified
Sep 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nicotinamide Riboside (NR)
    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 \[D17-19\].
  • Placebo Comparator: Placebo
    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 \[D17-19\].

Primary Outcome Measure

Feasibility of enrollment in a double-blind placebo-controlled supplementation trial in mothers of infants who are hospitalized. [ Time Frame: Within 4 days post-delivery of the infant. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-

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University of California, Davis· Sacramento, CA

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