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
About this trial
This is an interventional treatment trial for Preterm Birth
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)
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
NCT ID
NCT04614714
First Posted
October 22, 2020
Last Updated
June 9, 2023
Sponsor
University of California, Davis
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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