80 Participants Needed

Vitamin D for Maternal Stress

Recruiting at 1 trial location
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Idaho

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if vitamin D can reduce stress and improve mental health for mothers in Idaho who have given birth to preterm infants. Researchers seek to discover whether vitamin D can lower the risk of postpartum depression, which is more prevalent in these mothers. The trial will compare the effects of vitamin D supplements with a placebo (a pill with no active ingredients). Mothers of preterm infants who are up to four months postpartum and reside in Idaho may be suitable candidates for this trial. As an unphased study, this trial provides mothers the opportunity to contribute to important research that could enhance postpartum care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that taking vitamin D supplements is usually safe when adhering to recommended amounts. Studies have found that vitamin D can improve birth weight and reduce the risk of pregnancy complications such as pre-eclampsia, which can cause high blood pressure. However, excessive vitamin D intake can lead to issues like elevated calcium levels in the blood or kidney stones. Therefore, following the dosing guidelines provided by healthcare providers is crucial for safety.12345

Why are researchers excited about this trial?

Unlike the standard treatments for maternal stress, which often include therapy, lifestyle changes, or medications like antidepressants, Vitamin D is a simple, natural supplement that could offer benefits with fewer side effects. Researchers are excited about Vitamin D because it plays a crucial role in brain health and mood regulation, potentially addressing stress at a biological level. Its ability to be easily administered as a daily supplement adds to its appeal, offering a non-invasive alternative that might improve maternal well-being effectively and safely.

What evidence suggests that vitamin D might be an effective treatment for postpartum depression?

Research has shown that vitamin D supplements can greatly benefit mothers' health by reducing stress and improving mood. In this trial, some participants will receive vitamin D supplements, which studies have found decrease cellular damage and boost the body's natural defenses, potentially benefiting mental health. Low vitamin D levels link to a higher risk of early birth and other pregnancy issues, increasing stress for mothers. Vitamin D supplements can help lower these risks. While more research is needed to understand its direct effect on postpartum depression, evidence suggests that vitamin D might improve mental well-being in mothers of premature babies.13567

Are You a Good Fit for This Trial?

This trial is for mothers in Idaho who have recently given birth to preterm infants and are experiencing high levels of stress, which may lead to postpartum depression. Participants should not have other factors that could affect mental health or milk composition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vitamin D supplementation or placebo to assess its impact on maternal mental health and milk composition

8 weeks
3 visits (in-person) at baseline, 4-week, and 8-week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vitamin D (Cholecalciferol)
Trial Overview The study tests if Vitamin D supplements can improve the mental health of these mothers and alter the composition of their breast milk. It compares the effects of Vitamin D against a placebo in a controlled environment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin DExperimental Treatment1 Intervention
Group II: Placebo ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Idaho

Lead Sponsor

Trials
21
Recruited
2,800+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

Effect of Vitamin D supplementation during pregnancy on ...Vitamin D deficiency was related to a higher risk of maternal complications including preeclampsia, impaired glucose tolerance, and cesarean section rate.
Effects of vitamin D in pregnancy on maternal and offspring ...For maternal outcomes, a low level of vitamin D ( < 50 nmol/L), significantly increased the risk of preterm birth (OR = 1.28; 95% CI = 1.08–1. ...
The impact of vitamin D changes during pregnancy on the ...This study provides evidence that maternal vitamin D changes during pregnancy have a significant impact on MAE.
The effect of vitamin D supplementation on oxidative stress ...In the present study, vitamin D supplementation led to increased levels of 25(OH)D, TAC and GSH and also decreased concentration of MDA.
Effectiveness of Prenatal Vitamin D Deficiency Screening and ...This study demonstrated that as vitamin D supplementation increased from 400 to 4000 IU/d, birth complications decreased. These results also argue for the ...
Cholecalciferol (vitamin D3): efficacy, safety, and ...While vitamin D supplementation is generally safe within recommended limits, excessive intake may cause hypercalcemia or nephrolithiasis, emphasizing the need ...
High-Dose Vitamin D Supplementation in Pregnancy and ...This secondary analysis of a randomized clinical trial found that maternal high-dose vitamin D 3 supplementation during pregnancy did not improve ...
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