CClinicalTrials.gg
RecruitingNCT06919718Updated Sep 15, 2026

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

An interventional study of Vitamin D (Cholecalciferol ) and Placebo in Maternal Stress, sponsored by University of Idaho. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of Idaho · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Maternal Stress
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Mothers (\<18 years of age) of newborn infants (within first 4 months postpartum)
  • Infants not anticipated to survive >72 hours
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Placebo Control

    Other: Placebo

  • Experimental
    Vitamin D

    Dietary Supplement: Vitamin D (Cholecalciferol )

Interventions

  • Dietary supplementVitamin D (Cholecalciferol )

    2,000 IU Vitamin D

  • OtherPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: baseline, 4-week, 8-week

  3. Maternal Vitamin D status

    Blood vitamin D concentration

    Time frame: baseline, 4-week, 8-week

Secondary outcomes

  1. Maternal Self-Compassion

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

    Time frame: 8-week

  2. Maternal physiologic stress

    Blood and salivary cortisol

    Time frame: baseline, 4-week, 8-week

  3. Physiologic Maternal Self-compassion

    Blood oxytocin concentrations

    Time frame: baseline, 4-week, 8-week

  4. Milk Immunomodulatory Composition

    Milk Immunomodulatory protein concentrations

    Time frame: baseline, 4-week, 8-week

Other outcomes

  1. Maternal Diet

    Diet assessed using 24-hour diet recall

    Time frame: baseline, 4-week, 8-week

06

Study locations

2 of 2 sites recruiting
  • Kootenai Health
    Coeur d'Alene, Idaho 83814, United States
    • Brook Lane, MD · Contact · BLang@kh.org · 208-625-4000
    • Emily Kelley · Contact · ekelley@kh.org · 208-625-5275
    • Brook Lane · Sub investigator
    Recruiting
  • University of Idaho
    Moscow, Idaho 83844, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06919718
Lead sponsor
University of Idaho
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
Dec 4, 2024
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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