Recruiting

Vitamin D Supplementation

Sponsor:

University of Idaho

Code:

NCT06919718

Conditions

Maternal Stress

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Vitamin D (Cholecalciferol )

Placebo

Study Details

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

Study ID

NCT06919718

Start date

Dec 4, 2024

Status verified date

Jul, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Control

experimental: Vitamin D

Interventions

Vitamin D (Cholecalciferol )

2,000 IU Vitamin D

Placebo

Placebo

Primary outcome measure

  • Maternal Stress [ Time Frame: baseline, 4-week, 8-week ]
  • Maternal Depression [ Time Frame: baseline, 4-week, 8-week ]
  • Maternal Vitamin D status [ Time Frame: baseline, 4-week, 8-week ]

Central Contacts and Locations

Locations

Kootenai Health

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

University of Idaho

Recruiting

Moscow, Idaho, United States, 83844

Contacts

Principal Investigator:

Yimin Chen

More Information

Sponsor

University of Idaho

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Idaho on 2025-08-01.