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| ID | Type | Description | Link |
|---|---|---|---|
| MO230047 | Other Grant/Funding Number | United States Army Medical Research and Material Command, Military Operational Medicine Research Program (MOMRP) |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Daily self-administration of two 2,000 International Unit (IU) vitamin D3 tablets for 8 weeks. |
|
| Placebo | Placebo Comparator | Daily self-administration of two placebo tablets for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (Cholecalciferol) | Dietary Supplement | 4,000 IU daily oral administration for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage correct for No-Go trials in the Go/No-Go task | Measure of cognitive performance. Percentage correct for No-Go trials. | From baseline to the end of study product supplementation at 9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reaction time in the Psychomotor Vigilance Task | Measure of cognitive performance. Mean reaction time (millisecond) | From baseline to the end of study product supplementation at 9 weeks. |
| Scale scores of The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ihori Kobayashi, Ph.D. | Contact | 301-319-9287 | ihori.kobayashi.ctr@health.mil | |
| Lonique Moore, MSPH | Contact | 301-319-9287 | lonique.t.moore.ctr@health.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Research Center (SRC), Walter Reed Army Institute of Research (WRAIR) | Recruiting | Silver Spring | Maryland | 20910 | United States |
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| ID | Term |
|---|---|
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Oral Placebo Tablet | Dietary Supplement | Daily administration of two oral placebo tablets for 8 weeks |
|
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. |
| 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. | 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. | 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 | Saliva samples are collected during periprocedural periods of laboratory stress task at baseline and at the end of study product supplementation at 9 weeks. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |