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Maternal StressNCT06919718

Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho

A study testing Vitamin D (Cholecalciferol ) in people with Maternal Stress, run by University of Idaho at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. Read more about this study

Who is it for?
Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Stress
What is being tested?
Vitamin D (Cholecalciferol )
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
4 Dec 2024to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Mothers (>/= 18 years of age) of newborn infants (within first 4 months postpartum) in Idaho

Who cannot join

  • Mothers (<18 years of age) of newborn infants (within first 4 months postpartum)
  • Infants not anticipated to survive >72 hours

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Kootenai Health

    Coeur d'Alene, Idaho, 83814

    Brook Lane, MD, 208-625-4000, BLang@kh.org

    Emily Kelley, 208-625-5275, ekelley@kh.org

    Recruiting
  • University of Idaho

    Moscow, Idaho, 83844

    Yimin Chen, PhD, RDN, 208-885-6546, yiminc@uidaho.edu

    Sara Schumacher, schu2500@vandals.uidaho.edu

    Recruiting

Other trials in United States

About this study

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

Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. As many as 70% of mothers of preterm infants experience postpartum depression compared to only 12.5% of those delivering full-term infants. Increased stress and depression during this critical period are detrimental because they hamper a mother's ability to care for her infant and are associated with increased neonatal sepsis and mortality, decreased neonatal growth, and delayed motor and cognitive development. Postpartum depression is also associated with excessive maternal weight gain and risk for metabolic diseases, anxiety, and sleep disturbances. Stress in breastfeeding mothers can also alter circulating concentrations of some bioactive components (e.g., immunoglobulins, cortisol) that can transfer into milk. As such, understanding factors predisposing these vulnerable women to extreme levels of stress and finding ways to lower this stress and lessen its negative health outcomes on mothers and infants are important public health challenges. The March of Dimes estimates that 8.5% of births in Idaho are preterm, making this topic particularly relevant for Idaho women. Risk factors for postpartum depression in mothers delivering term or preterm infants are complex, but maternal nutrient deficiencies may be involved. Vitamin D status, for instance, is inversely correlated with risk of postpartum depression in women delivering term infants. However, vitamin D interventions have yielded inconsistent results, perhaps due to confounding impacts of geographic location, skin color, and endogenous vitamin D synthesis. Endogenous vitamin D synthesis requires cutaneous sunlight exposure, placing Idaho women at even greater risk of vitamin D deficiency - particularly in the winter when days are extremely short (only 7 hr on the winter solstice). The impact of maternal vitamin D supplementation during lactation on infant variables (e.g., vitamin D status) has been examined. However, its effect on maternal mental health has not been rigorously studied - let alone in the 'frontier and remote' (FAR) rural West, including Idaho, with short periods of wintertime sunlight and poor access to healthcare. Our long term goal is to develop interventions to improve maternal and infant health in Idaho - particularly in the context of preterm births. The overall primary objective of this proposal is to determine if maternal vitamin D supplementation improves vitamin D status and mental health in Idahoan mothers of preterm infants. Our central hypothesis is that vitamin D supplementation improves vitamin D status and reduces stress and other indicators of poor postpartum maternal mental health in Idaho women delivering preterm infants. Secondarily, we will assess the effects of maternal vitamin D supplementation on human milk composition.

Conditions
Maternal Stress
Being tested
Vitamin D (Cholecalciferol ), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D (Cholecalciferol )Dietary supplement

    2,000 IU Vitamin D

  • PlaceboOther

    Placebo

Study groups in NCT06919718
Study groupRoleWhat they receive
Placebo ControlPlacebo comparatorNot described
Receives: Other: Placebo
Vitamin DExperimentalNot described
Receives: Dietary Supplement: Vitamin D (Cholecalciferol )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Stress

    Maternal stress measured by the validated questionnaire: Perceived Stress Scale (PSS).

    The PSS can range from 0 to 40 with higher scores indicating higher perceived stress:

    0-13 = low stress 14-26 = moderate stress 27-40 = high stress

    Measured: baseline, 4-week, 8-week

  2. Maternal Depression

    Maternal depression measured using the validated questionnaire: Edinburgh Postnatal Depression Scale.

    The Edinburgh Postnatal Depression Scale can range from 0 to 30 with higher scores indicating higher depression. Any total score >10 indicates depression.

    Measured: baseline, 4-week, 8-week

  3. Maternal Vitamin D status

    Blood vitamin D concentration

    Measured: baseline, 4-week, 8-week

Secondary outcomes (4)
  1. Maternal Self-Compassion

    Maternal self-compassion measured using the validated Self-Compassion-Short Form

    Measured: 8-week

  2. Maternal physiologic stress

    Blood and salivary cortisol

    Measured: baseline, 4-week, 8-week

  3. Physiologic Maternal Self-compassion

    Blood oxytocin concentrations

    Measured: baseline, 4-week, 8-week

  4. Milk Immunomodulatory Composition

    Milk Immunomodulatory protein concentrations

    Measured: baseline, 4-week, 8-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start4 Dec 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919718
Sponsor's protocol ID
IRB 20-024
Other IDs
P20GM152304
Status last verified
Sep 2026
First submitted
2 Apr 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D (Cholecalciferol ) in people with Maternal Stress, run by University of Idaho at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Stress (time frame: baseline, 4-week, 8-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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