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Search / Trial NCT04614714

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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Oct 28, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a supplement called nicotinamide riboside (NR) can help mothers of very premature infants produce more breast milk. Breastfeeding is important for newborns, especially those born early, as it provides essential nutrients and support for their development. The researchers believe that NR, which helps with energy production in the body, may boost milk supply in breastfeeding mothers. In this study, mothers will be given either the NR supplement or a placebo (a substance with no effect) during two different phases, and the researchers will measure how much milk they produce.

To be eligible for this trial, mothers must be willing to provide consent for themselves and their infants, and they must have given birth to a baby at 28 weeks of gestation or earlier, either at the UC Davis Medical Center or transferred there shortly after birth. Participants should also be ready to measure and record their milk production. However, certain conditions, such as previous breast surgery or certain medical treatments, may prevent someone from joining. If you participate, you can expect to be closely monitored, and your contribution could help improve breastfeeding support for mothers of preterm infants in the future.

Gender

FEMALE

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)

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Sacramento, California, United States

Patients applied

0 patients applied

Trial Officials

Kara Khun-Riordon, MD

Principal Investigator

UC Davis

Nicole Cacho, DO

Principal Investigator

UC Davis

Luna Khanal, MD

Principal Investigator

UC Davis

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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