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

NCT06919718 | Recruiting

• 2 other identifiers: IRB 20-024P20GM152304
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Maternal Stress

Outcome Measures

Primary Outcomes (3)

• 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

  baseline, 4-week, 8-week

• 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.

  baseline, 4-week, 8-week

• Maternal Vitamin D status

  Blood vitamin D concentration

  baseline, 4-week, 8-week

Secondary Outcomes (4)

• Maternal Self-Compassion

  8-week

• Maternal physiologic stress

  baseline, 4-week, 8-week

• Physiologic Maternal Self-compassion

  baseline, 4-week, 8-week

• Milk Immunomodulatory Composition

  baseline, 4-week, 8-week

Other Outcomes (1)

• Maternal Diet

  baseline, 4-week, 8-week

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Other: Placebo

Vitamin D

EXPERIMENTAL

Dietary Supplement: Vitamin D (Cholecalciferol )

Interventions

Vitamin D (Cholecalciferol ) DIETARY_SUPPLEMENT

2,000 IU Vitamin D

Vitamin D

Placebo OTHER

Placebo

Placebo Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Idaho: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

Kootenai Health

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

University of Idaho

Moscow, Idaho, 83844, United States

RECRUITING

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (2)