Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
FEMALE
Healthy Volunteers
ID06919718

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

Age: 18Years - 64Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Mothers younger than 18 years of age
  • Infants not expected to survive more than 72 hours

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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