Acute Stress ReactionNCT07654777
The Efficacy of Vitamin D Supplementation to Sustain Performance Outcomes
A study testing Vitamin D3 (Cholecalciferol) in people with Acute Stress Reaction, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Reaction
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age.
- Females of child-bearing potential must be using some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
- Score of 80% or greater on a "Volunteer Comprehension Assessment" test. A maximum of two attempts is permitted.
- Blood 25 hydroxy vitamin D [25(OH)D] levels at the Screening visit of 30 nmol/L (12 ng/mL) (inclusive) - < 75 nmol/L (30 ng/mL).
Who cannot join
- Contraindications due to vitamin D supplementation, including a history of hypercalcemia, malabsorption syndrome, hypervitaminosis D, or allergic/hypersensitivity reactions to vitamin D or a history of other adverse reactions to vitamin D supplementation.
- Taking a vitamin D3 or D2 supplement or a supplement containing vitamin D3 or D2 (excluding vitamin D-fortified foods) during the participation. Volunteers who take vitamin D3 or D2 supplement before their participation can be eligible if they agree to stop taking the supplement(s) starting 1 month prior to the enrollment/baseline visit until the end of the post-supplementation visit. Blood 25(OH)D levels of the volunteers who stopped taking the supplements after the screening visit will be tested before the Enrollment/Baseline visit to ensure their 25(OH)D fall within the inclusionary ranges. Volunteers who are not able to stop taking vitamin D supplements or supplements containing vitamin D due to medical/health or any other reasons (especially if the volunteer is taking supplements containing vitamin D under the direction of a healthcare provider) are not eligible.
- Not being able to tolerate electric shocks delivered through the stress belt.
- Self-reported propensity for adverse skin reactions, such as excessive irritation, burning, itching, hives, and redness, in response to physical or heat stimuli.
- A history of abuse or addiction to recreational or illicit drugs (including marijuana and alcohol) or prescribed medications (e.g., opioids) (diagnosed or suspected based on the medical history).
- Use a nicotine product (e.g., cigarette, cigar, vape) more than 3 days per week or not be able to go without using these products during any lab visits.
Show all 40Show fewer
- Self-reported caffeine use in excess of 600 mg (e.g., approximately 10 caffeinated sodas or approximately 29 ounces of brewed coffee) per day on average or not being able to go without caffeine during the in-lab visits.
- History of neurologic disorder (to include but not limited to epilepsy, hydrocephalus, multiple sclerosis). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) or a history of mild traumatic brain injury may be deemed non-exclusionary at the discretion of the examining study medical investigator.
- Score of 10 or above on the Beck Depression Inventory (BDI) or a score of > 0 on item 9 "Suicidal Thoughts or Wishes" of the BDI.
- Score of 33 or above on the Posttraumatic Stress Disorder (PTSD) Checklist, 5th Edition.
- Score 20 or above on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety-7-Item Short form.
- History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction).
- Asthma, any type of reactive airways disease, or any pulmonary disease requiring daily inhaler use.
- Regularly work night shifts or have a habitual sleep/wake schedule that is not conducive for the optimal performance on cognitive, physical, and/or emotional tasks during the study visits (e.g., extremely early or late habitual bedtime or rise time; to be determined on a case-by-case basis by the principal investigator or an associate investigator).
- A diagnosis of sleep apnea.
- Kidney disease or kidney abnormalities, liver disease or liver abnormalities, or any other metabolic derangements (endocrine disorders, hyperglycemia, etc.) that could alter neurophysiological function.
- History of kidney stones.
- Osteoporosis or low bone density.
- Self-reported history of hospitalization for a psychiatric disorder within the past year or with a previous history of a psychotic, bipolar disorder or personality disorder. For a history of a diagnosis of any other psychiatric disorder, the potential participant's symptoms must either be resolved to a degree that a diagnosis is no longer applied or their symptoms must have been stabilized by pharmacological or nonpharmacological treatments for a period of at least 90 days or greater as deemed exclusionary or non-exclusionary at the discretion of the examining study medical investigator.
- Self-reported or suspected current use of antipsychotics, anticonvulsants, or mood stabilizers, to be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected current use of products or drugs that have central nervous system depressant effects, to be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected use of products or drugs that are contraindicated to the study supplement or significantly affect the participant's study performance and that cannot be safely discontinued during the study participation. To be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected current heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week for males and 7 drinks per week for females or as determined by the examining study medical investigator).
- (Females only) Positive urine pregnancy test result.
- (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk.
- Resting blood pressure above 140/90 or resting pulse > 110 beats per minute.
- Body Mass Index (BMI) ≥ 31. The inclusion of individuals with BMI between 30 and 31 (Obese Class I) will be determined using medical investigator's discretion.
- Clinically significant values (as determined by the reviewing study medical investigator) for any hematology or chemistry parameter.
- Positive urine drug result at any study visits. If tetrahydrocannabinol is positive at the screening visit and the volunteer wishes to have the second drug test, the volunteer will be allowed to have one additional urine drug test after a 1 to 5-month waiting period.
- Positive saliva alcohol result at any study visits.
- Inability to read (i.e., failing in the Volunteer Comprehension Assessment twice) and sign consent.
- Failure to obtain required approved official leave to participate (federal civilian employees and active-duty military only).
- Failure to cooperate with requirements of the study.
- Self-reported or suspected current use of illicit drugs (including but not limited to benzodiazepines, amphetamines, and cocaine). In case of marijuana/tetrahydrocannabinol product use, the frequency up to twice a month will not be excluded. Current use of any other drugs at any frequency is excluded.
- Current use and/or prescription for any medication the medical investigator determines would interact adversely with vitamin D supplementation, including but not limited to: orlistat, statins, corticosteroid medications, and thiazide diuretics.
- Current diabetes.
- Gastrointestinal disorders - motility disorders that might affect vitamin D absorption.
- Failure to provide a social security number or tax identification number in order to be paid for screening and participation in the study.
- Current participation in another ongoing clinical trial.
- Prior participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sleep Research Center (SRC), Walter Reed Army Institute of Research (WRAIR)
Silver Spring, Maryland, 20910
Lonique Moore, MSPH, 301-319-9287, lonique.t.moore.ctr@health.mil
Beza Negash, BS, BA, 301-319-9287, beza.w.negash.ctr@health.mil
About this study
Official title: Assessment of the Efficacy of Vitamin D Supplementation to Sustain Performance of Military-Relevant Laboratory Tasks Under Acutely Stressed Conditions: A Randomized, Double-Blind, Placebo-Controlled Study
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:
Read more
- 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.
- Conditions
- Acute Stress Reaction
- Being tested
- Vitamin D3 (Cholecalciferol), Oral Placebo Tablet
- Keywords
- acute stress reaction, vitamin D, electrical shocks, neuropsychological tests, randomized controlled trial
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
4,000 IU daily oral administration for 8 weeks.
Oral Placebo TabletDietary supplement
Daily administration of two oral placebo tablets for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Daily self-administration of two 2,000 International Unit (IU) vitamin D3 tablets for 8 weeks. Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| Placebo | Placebo comparator | Daily self-administration of two placebo tablets for 8 weeks. Receives: Dietary Supplement: Oral Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage correct for No-Go trials in the Go/No-Go task
Measure of cognitive performance. Percentage correct for No-Go trials.
Measured: From baseline to the end of study product supplementation at 9 weeks.
Secondary outcomes (5)
Mean reaction time in the Psychomotor Vigilance Task
Measure of cognitive performance. Mean reaction time (millisecond)
Measured: From baseline to the end of study product supplementation at 9 weeks.
Scale scores of The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale
The ANAM mood consists of seven scales: Vigor, Restless, Depression, Anger, Fatigue, Anxiety, and Happiness. For each scale, the range of score is 0 - 6, and a higher score indicates greater intensity of the respective mood.
Measured: From baseline to the end of study product supplementation at 9 weeks.
Sway indices of Biosway
Sway indices will be obtained for Eyes open firm surface, Eyes closed firm surface, Eyes open foam surface, and Eyes closed foam surface. A higher index score indicates greater sway of the body.
Measured: From baseline to the end of study product supplementation at 9 weeks.
Average Heart rate
Continuous measure of heart rate to assess autonomic nervous system activity before, during, and after the laboratory stress task.
Measured: Heart rates are measured during the periprocedural periods of laboratory stress task at baseline and at the end of study product supplementation at 9 weeks.
Concentration of alpha-amylase in saliva
Measure of sympathetic nervous system activation
Measured: Saliva samples are collected during periprocedural periods of laboratory stress task at baseline and at the end of study product supplementation at 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start17 Jul 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654777
- Sponsor's protocol ID
- WRAIR #3286
- Other IDs
- MO230047
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Vitamin D Supplementation to Sustain Performance of Military-Relevant Laboratory Tasks Under Acutely Stressed Conditions: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07654777
- Acronym / sponsor ID
- WRAIR #3286
- Conditions
- Acute Stress Reaction
- Keywords
- acute stress reaction, vitamin D, electrical shocks, neuropsychological tests, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol)Daily self-administration of two 2,000 International Unit (IU) vitamin D3 tablets for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Oral Placebo TabletDaily self-administration of two placebo tablets for 8 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age.
- Females of child-bearing potential must be using some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
- Score of 80% or greater on a "Volunteer Comprehension Assessment" test. A maximum of two attempts is permitted.
- Blood 25 hydroxy vitamin D [25(OH)D] levels at the Screening visit of 30 nmol/L (12 ng/mL) (inclusive) - < 75 nmol/L (30 ng/mL).
Key exclusion criteria (40 listed)
- Contraindications due to vitamin D supplementation, including a history of hypercalcemia, malabsorption syndrome, hypervitaminosis D, or allergic/hypersensitivity reactions to vitamin D or a history of other adverse reactions to vitamin D supplementation.
- Taking a vitamin D3 or D2 supplement or a supplement containing vitamin D3 or D2 (excluding vitamin D-fortified foods) during the participation. Volunteers who take vitamin D3 or D2 supplement before their participation can be eligible if they agree to stop taking the supplement(s) starting 1 month prior to the enrollment/baseline visit until the end of the post-supplementation visit. Blood 25(OH)D levels of the volunteers who stopped taking the supplements after the screening visit will be tested before the Enrollment/Baseline visit to ensure their 25(OH)D fall within the inclusionary ranges. Volunteers who are not able to stop taking vitamin D supplements or supplements containing vitamin D due to medical/health or any other reasons (especially if the volunteer is taking supplements containing vitamin D under the direction of a healthcare provider) are not eligible.
- Not being able to tolerate electric shocks delivered through the stress belt.
- Self-reported propensity for adverse skin reactions, such as excessive irritation, burning, itching, hives, and redness, in response to physical or heat stimuli.
- A history of abuse or addiction to recreational or illicit drugs (including marijuana and alcohol) or prescribed medications (e.g., opioids) (diagnosed or suspected based on the medical history).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (Cholecalciferol)4,000 IU daily oral administration for 8 weeks. | Dietary supplement | Vitamin D3 |
| Oral Placebo TabletDaily administration of two oral placebo tablets for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Percentage correct for No-Go trials in the Go/No-Go task
Time frame: From baseline to the end of study product supplementation at 9 weeks.
Measure of cognitive performance. Percentage correct for No-Go trials.
5 secondary outcomes
Mean reaction time in the Psychomotor Vigilance Task
Time frame: From baseline to the end of study product supplementation at 9 weeks.
Scale scores of The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale
Time frame: From baseline to the end of study product supplementation at 9 weeks.
Sway indices of Biosway
Time frame: From baseline to the end of study product supplementation at 9 weeks.
Average Heart rate
Time frame: Heart rates are measured during the periprocedural periods of laboratory stress task at baseline and at the end of study product supplementation at 9 weeks.
Concentration of alpha-amylase in saliva
Time frame: Saliva samples are collected during periprocedural periods of laboratory stress task at baseline and at the end of study product supplementation at 9 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (Cholecalciferol) in people with Acute Stress Reaction, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ihori Kobayashi, Ph.D. (301-319-9287, ihori.kobayashi.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage correct for No-Go trials in the Go/No-Go task (time frame: From baseline to the end of study product supplementation at 9 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.