Actively Recruiting
Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
Led by University of Idaho · Updated on 2025-08-01
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Idaho
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Mothers of preterm infants face higher emotional stress and a greater risk of postpartum depression compared to mothers of full-term infants. This increased stress can negatively affect both the mother's ability to care for her baby and the infant's health and development. The study focuses on mothers in Idaho, where preterm births are common and vitamin D deficiency risk is heightened due to limited winter sunlight exposure, which may influence postpartum mental health. The trial is evaluating whether vitamin D supplementation during lactation improves vitamin D levels and reduces stress and depression in mothers of preterm infants. Participants are randomly assigned to receive either 2,000 IU of vitamin D or a placebo. The study includes a triple-blind design and measures outcomes at baseline, 4 weeks, and 8 weeks to assess maternal stress, depression, vitamin D status, and milk composition. During the study, mothers will have their mental health, physiological stress, self-compassion, and vitamin D levels monitored through questionnaires and laboratory tests at three time points. Researchers will also analyze the immunomodulatory components in breast milk. The total participation period lasts 8 weeks, with careful follow-up to understand the effects of vitamin D supplementation on both mother and infant health.
CONDITIONS
Brief Title
Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers 18 years of age or older
- Mothers of newborn infants within first 4 months postpartum
- Mothers living in Idaho
You will not qualify if you...
- Mothers younger than 18 years of age
- Infants not expected to survive more than 72 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either Vitamin D supplements or placebo to evaluate the impact on maternal stress, depression, and vitamin D status.
3 visits at baseline, 4 weeks, and 8 weeks
Trial Site Locations
Total: 2 locations
1
Kootenai Health
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
2
University of Idaho
Moscow, Idaho, United States, 83844
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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