Search > Acute Stress Disorder
52 Participants NeededMy employer runs this trial

Vitamin D for Acute Stress Disorder

IK
LM
Overseen ByLonique Moore, MSPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Walter Reed Army Institute of Research (WRAIR)
Must not be taking: Antipsychotics, Anticonvulsants, Mood stabilizers, others
Disqualifiers: Hypercalcemia, Drug abuse, Cardiovascular disease, Asthma, Diabetes, others

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to find out if vitamin D supplements help healthy adults maintain their cognitive and simple physical task performance and emotional state during highly stressful situations.

The main question it aims to answer is:

\- Does vitamin D help maintain cognitive and physical task performance and emotional state during highly stressful situations?

Researchers will compare vitamin D to placebo (a look-alike tablet that contains no active ingredients) to see if vitamin D better maintain cognitive and physical task performance and emotional state during highly stressful situations.

Participants will:

* Take vitamin D or placebo tablets daily for 8 weeks.

* Perform cognitive and simple physical tasks and rate their emotional state under highly stressful situations.

* Wear a stress belt that delivers mild electric shocks 1 - 5 times while participants are performing laboratory tasks.

* Wear a wristwatch-shaped activity monitor for 9 weeks.

* Visit the laboratory 5 times.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-40 with low to moderate vitamin D levels. Participants must not be pregnant or breastfeeding, have certain medical or psychiatric conditions, use specific medications or substances, or have a history of severe reactions to vitamin D. They must also tolerate mild electric shocks and follow study rules.

Inclusion Criteria

Blood 25 hydroxy vitamin D levels at screening between 30 nmol/L (12 ng/mL) inclusive and less than 75 nmol/L (30 ng/mL)
I am a male or a non-pregnant, non-lactating female between 18 and 40 years old.
I scored at least 80% on the comprehension test within two tries.
See 1 more

Exclusion Criteria

Inability to tolerate electric shocks delivered through the stress belt
Use of nicotine products more than 3 days per week or inability to abstain during lab visits
Self-reported caffeine use exceeding 600 mg per day or inability to abstain during lab visits
See 37 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take vitamin D or placebo tablets daily for 8 weeks and perform cognitive and physical tasks under stress

8 weeks
5 visits (in-person)

Monitoring

Participants wear a wristwatch-shaped activity monitor for 9 weeks

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vitamin D3 (Cholecalciferol)

Trial Overview

The study tests whether taking daily vitamin D supplements for 8 weeks helps maintain thinking skills, simple physical performance, and emotional state during stressful situations compared to a placebo tablet. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin D3Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)

Lead Sponsor

Trials
111
Recruited
108,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.