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NCT06919718 · ClinicalTrials.gov registry record · NA

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

A NA study of Maternal Stress, sponsored by University of Idaho.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
2
Study locations

NCT06919718: Recruiting NA study of Maternal Stress, sponsored by University of Idaho.

NCT06919718 is a NA study of Maternal Stress that is actively recruiting participants, run by University of Idaho. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06919718, a NA study of Maternal Stress, is actively recruiting participants, sponsored by University of Idaho.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
2
Study locations

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 s

Primary Outcome

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

Conditions Studied

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Vitamin D (Cholecalciferol )

Study Locations (2)

Idaho

  • Kootenai Health - Coeur d'Alene
  • University of Idaho - Moscow

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-12-04
Est. Completion 2027-05-31
Phase NA
University of Idaho

14 total trials

What NCT06919718 shows while recruiting

NCT06919718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Maternal Stress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06919718 reports a single indexed study location in Idaho.

Frequently Asked Questions

What is clinical trial NCT06919718 about?

NCT06919718 is a clinical study titled "Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho". 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% ...

What is the current status of trial NCT06919718?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2024-12-04. Estimated completion is 2027-05-31.

What conditions does trial NCT06919718 study?

This clinical trial studies the following conditions: Maternal Stress.

What interventions are being tested in trial NCT06919718?

The interventions under investigation include: Placebo (OTHER), Vitamin D (Cholecalciferol ) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06919718?

This trial is sponsored by University of Idaho, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06919718 being conducted?

This trial has 2 study locations across Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06919718's enrollment target sits among peer trials

80 995th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06919718, the US trial registry maintained by the National Library of Medicine. NCT06919718 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.