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

Study acronym: MOONRISE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jun 30, 2026 → Aug 30, 2027
See other at-risk trials from University of California, Davis

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jun 30, 2026 to Aug 30, 2027
    • Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Aug 19, 2026
    • Site details revised
    v17
  2. Notable Primary and study completion moved earlier from Dec 31, 2027 to Jun 30, 2026
    • Start date: Apr 1, 2026 to Jun 1, 2026
    v16
  3. Notable Start date: Jan 20, 2026 to Apr 1, 2026v15
  4. Notable Primary completion date: Dec 2026 to Dec 31, 2027v14 Show 11 more changesShow less
    • Start date: Dec 1, 2024 to Jan 20, 2026
    • Primary endpoint revised
    • Trial status: Recruiting to Not Yet Recruiting
    • Enrollment target: 32 to 40
    • Study completion date: Dec 2027 to Dec 31, 2027
    • Interventions: Nicotinamide riboside chloride (Drug), Placebo (Drug) to Nicotinamide Riboside (NR) (Other), Placebo (Other)
    • Eligibility criteria expanded, about 155 words
    • Secondary endpoints: 10 to 16
    • Study description expanded, about 352 words
    • Study site revised
    • Collaborators expanded, about 2 words
  5. Minor Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2024 to Dec 1, 2024
    v12
  2. Minor Re-verified, no change to tracked fieldsv11
  3. Notable Primary completion date: Oct 2023 to Dec 2026
    • Start date: Jan 2023 to Dec 2024
    • Study completion date: Dec 2023 to Dec 2027
    v10
  4. Notable Primary completion date: Jul 2022 to Oct 2023
    • Start date: Jan 2022 to Jan 2023
    • Study completion date: Jul 2022 to Dec 2023
    v9
  5. Notable Start date: Aug 2021 to Jan 2022v8
  6. Notable Start date: May 2021 to Aug 2021
    • Primary completion date: Jun 2022 to Jul 2022
    v7
  7. Notable Start date: Feb 2021 to May 2021v6 Show 4 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Dec 2021 to Jun 2022
    • Study completion date: Feb 2022 to Jul 2022
    • Secondary endpoints: 8 to 10
  8. Notable Start date: Dec 2020 to Feb 2021v5
  9. Minor Study title expanded, about 6 wordsv4
  10. Minor Study title shortened, about 3 wordsv3
  11. Minor Study title expanded, about 3 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04614714
Lead Sponsor University of California, Davis
Collaborators: ChromaDex, Inc.
Conditions
(from sponsor)
Preterm Birth, Inadequate Milk Production
Related terms Premature Birth
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov