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

Primary Purpose

Preterm Birth, Inadequate Milk Production

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nicotinamide riboside chloride
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • informed consent for participation of both mother and baby
  • infant delivered at ≤28 weeks gestation
  • Infant born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 6 days of life.
  • Mothers willing to express and measure milk volume

Exclusion Criteria:

  • Infant is participating in an intervention trial that could influence growth, development, or feeding tolerance
  • Mother has previously undergone breast surgery or has experienced other breast trauma
  • Mother is actively using narcotics or amphetamines
  • Mothers is receiving cancer treatment
  • Mothers is receiving lithium or gold therapies
  • Mother plans to use any form of galactagogue (including fenugreek)
  • Mother is taking any form of contraceptives or plans to resume use of contraceptive within four weeks of delivery
  • Mother is involuntarily confined
  • Mother is an adult unable to consent
  • Mother resides <50 miles from UC Davis Medical Center
  • Anyone deemed unfit for participation by investigator(s)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    NR First

    Placebo First

    Arm Description

    Mothers will receive NR during the first 7 days of intervention, then placebo for the 7 days following washout.

    Mothers will receive placebo during the first 7 days of intervention, then NR for the 7 days following washout.

    Outcomes

    Primary Outcome Measures

    Difference in mean milk volume of expressed milk (mL) between NR and placebo
    Measured by 24-hour expressions

    Secondary Outcome Measures

    Difference in mean milk volume of expressed milk (mL) between NR and placebo
    Measured by 24-hour expressions
    Difference in change in mean milk volume between baseline and each time point (mL) between NR and placebo
    Measured by 24-hour expressions
    Difference in serum prolactin levels and the difference between NR and placebo
    Taken at two time points
    Concentration of fat, protein, and carbohydrates in expressed milk (g/100 mL)
    Concentration of metabolite species in maternal urine (μM) between NR and placebo
    Difference in mean size of milk fat globule (μm) between NR and placebo
    Average PC/PE ratio of milk fat globule membrane
    Oligosaccharide content of expressed milk
    Measured as relative abundance (%)
    Infant fecal microbiota
    Measured as relative abundance (%)
    Concentration of BDNF in expressed milk (pg/mL)

    Full Information

    First Posted
    October 22, 2020
    Last Updated
    June 9, 2023
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04614714
    Brief Title
    Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
    Acronym
    MOONRISE
    Official Title
    Nicotinamide Riboside and Milk Production in the NICU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2024 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. The investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (NR) during early postpartum will result in increased milk production. NR is a unique precursor to NAD+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. In lactating rats, NR supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. No studies have been conducted to date that explore the short- or long-term use of NR for increasing milk supply in lactating women. This study will follow a small cohort of women and very preterm infants in the NICU throughout two intervention phases-- one in which each mother will randomly receive either NR or a placebo, then the opposite treatment-- to determine the effect of maternal NR supplementation on expressed milk volume and other markers of metabolism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth, Inadequate Milk Production

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NR First
    Arm Type
    Experimental
    Arm Description
    Mothers will receive NR during the first 7 days of intervention, then placebo for the 7 days following washout.
    Arm Title
    Placebo First
    Arm Type
    Experimental
    Arm Description
    Mothers will receive placebo during the first 7 days of intervention, then NR for the 7 days following washout.
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotinamide riboside chloride
    Other Intervention Name(s)
    Niagen
    Intervention Description
    Nicotinamide riboside chloride 250 mg capsules, administered once per day (Day 1-7 or Day 11-17)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Maltodextrin placebo, administered once per day (Day 1-7 or Day 11-17)
    Primary Outcome Measure Information:
    Title
    Difference in mean milk volume of expressed milk (mL) between NR and placebo
    Description
    Measured by 24-hour expressions
    Time Frame
    Day 2 - Day 10
    Secondary Outcome Measure Information:
    Title
    Difference in mean milk volume of expressed milk (mL) between NR and placebo
    Description
    Measured by 24-hour expressions
    Time Frame
    Day 2 - Days 7, 12, 17, and 20
    Title
    Difference in change in mean milk volume between baseline and each time point (mL) between NR and placebo
    Description
    Measured by 24-hour expressions
    Time Frame
    Day 2 - Days 7 and 10; Day 12 - Days 17 and 20
    Title
    Difference in serum prolactin levels and the difference between NR and placebo
    Description
    Taken at two time points
    Time Frame
    Day 2 - Day 10
    Title
    Concentration of fat, protein, and carbohydrates in expressed milk (g/100 mL)
    Time Frame
    Day 2 - Day 20
    Title
    Concentration of metabolite species in maternal urine (μM) between NR and placebo
    Time Frame
    Day 2 - Day 20
    Title
    Difference in mean size of milk fat globule (μm) between NR and placebo
    Time Frame
    Day 10 - Day 20
    Title
    Average PC/PE ratio of milk fat globule membrane
    Time Frame
    Day 10 - Day 20
    Title
    Oligosaccharide content of expressed milk
    Description
    Measured as relative abundance (%)
    Time Frame
    Day 2 - Day 20
    Title
    Infant fecal microbiota
    Description
    Measured as relative abundance (%)
    Time Frame
    Day 2 - Day 20
    Title
    Concentration of BDNF in expressed milk (pg/mL)
    Time Frame
    Day 2 - Day 20
    Other Pre-specified Outcome Measures:
    Title
    Change in maternal weight (lbs.)
    Time Frame
    Day 2 - Day 20
    Title
    Infant length (cm)
    Time Frame
    Day 1 - Day 28
    Title
    Infant weight (g)
    Time Frame
    Day 1 - Day 28
    Title
    Infant head circumference (cm)
    Time Frame
    Day 1 - Day 28
    Title
    NICU outcomes
    Description
    Including morbidity, death, necrotizing enterocolitis, chronic lung disease, sepsis, etc.
    Time Frame
    Day 1 - Day 28

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: informed consent for participation of both mother and baby infant delivered at ≤28 weeks gestation Infant born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 6 days of life. Mothers willing to express and measure milk volume Exclusion Criteria: Infant is participating in an intervention trial that could influence growth, development, or feeding tolerance Mother has previously undergone breast surgery or has experienced other breast trauma Mother is actively using narcotics or amphetamines Mothers is receiving cancer treatment Mothers is receiving lithium or gold therapies Mother plans to use any form of galactagogue (including fenugreek) Mother is taking any form of contraceptives or plans to resume use of contraceptive within four weeks of delivery Mother is involuntarily confined Mother is an adult unable to consent Mother resides <50 miles from UC Davis Medical Center Anyone deemed unfit for participation by investigator(s)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruce German, PhD
    Phone
    (530) 752-1486
    Email
    jbgerman@ucdavis.edu

    12. IPD Sharing Statement

    Learn more about this trial

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

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