Clinical trial Recruiting at 1 site Interventional Ages 18 to 50 Women only

Mindfulness and Vitamin D for Mothers of Preterm Infants

Official title: Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes

Run by University of Idaho · NCT04821544 · Data updated 2026-11-12

This study tests if an 8-week mindfulness program and vitamin D supplements can help mothers of preterm infants feel less stressed and improve the quality of their milk.

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Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexWomen only
Enrollment500 (estimated)
SponsorUniversity of Idaho
Academic / other
Locations1 site (Coeur d'Alene, Idaho)
StatusRecruiting
StartedMay 1, 2021
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedNovember 10, 2026
Trial IDNCT04821544 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are mothers of newborn infants, particularly those with preterm infants, at Kootenai Health NICU and in the Palouse region.

Probably not a fit

Patients who are not mothers of newborn infants or those who do not have access to the study locations may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of an 8-week mindfulness-based intervention focused on self-compassion and vitamin D supplementation on maternal stress and human milk composition in mothers of preterm infants. Participants will be block randomized into three groups: standard care, mindfulness intervention, or vitamin D supplementation. Maternal stress levels and self-compassion will be assessed using validated scales, and biological samples will be collected to analyze changes in human milk and infant health outcomes. The goal is to determine if these interventions can improve maternal well-being and infant health.

Why it matters

Potential benefit: If successful, this study could enhance maternal mental health and improve the nutritional quality of human milk, leading to better health outcomes for infants.

How similar studies have gone: Other studies have shown promising results with mindfulness interventions in maternal health, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Mothers of newborn infants at Kootenai Health NICU and the Palouse region

Exclusion Criteria:

\-

Where it's running

  • Kootenai Health
    Coeur d'Alene, Idaho, United States
    Recruiting

Study contacts

  • Principal investigator: Yimin Chen, PhD — University of Idaho
  • Study coordinator: Yimin Chen, PhD
  • Email: yiminc@uidaho.edu
  • Phone: 2088857264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.