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| Name | Class |
|---|---|
| Wisconsin Department of Health and Family Services | OTHER_GOV |
| Haukeland University Hospital | OTHER |
| National Institute of Nutrition and Seafood Research, Norway | OTHER_GOV |
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The purpose of the project is to investigate whether an intervention program with vitamin D supplementation is able to improve the biology of stress resilience as well as subjective well-being in individuals with antisocial behavior problems (forensic inpatients).
This is a randomized control trial looking at the effects of vitamin D supplements on mental health in a group of forensic inpatients. More specific the effects of vitamin D will be investigated in relation to underlying biological mechanisms associated with resilience (e.g., serotonin, cortisol, heart rate variability and executive functioning), but also subjective well-being such as sleep quality, anxiety, depression, self-reported resilience and physical activity. About 100 participants will be randomized to an intervention group (vitamin D) or a control group (placebo). The intervention will last for 3-4 months. Pre-test will start in October/November 2017 and post-test in April/May 2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | Intervention is vitamin D supplement |
|
| Control group | Placebo Comparator | Placebo capsule contains olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D (40µg/day) will be compared with placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months) | Measured from blood sample | Time for blood sample: about 10-15 minutes (at both pre and post test) |
| Change in serotonin from pre-test (baseline) to post-test (after 4 months) | Measured form blood sample | Time for blood sample: about 10-15 minutes (at both pre and post test) |
| Change in total cholesterol from pre-test (baseline) to post-test (after 4 months) | Measured from blood sample | Time for blood sample: about 10-15 minutes (at both pre and post test) |
| Change in lipoproteins from pre-test (baseline) to post-test (after 4 months) | Measured from blood sample | Time for blood sample: about 10-15 minutes (at both pre and post test) |
| Change in triglycerides from pre-test (baseline) to post-test (after 4 months) | Measured from blood sample | Time for blood sample: about 10-15 minutes (at both pre and post-test) |
| Change in cortisol from pre-test (baseline) to post-test (after 4 months) | Saliva | 7 samples over 24 hours (at both pre and post-test) |
| Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months) | Computerized cognitive task |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep from pre-test (baseline) to post-test (after 4 months) | Measured by Ambulatory Monitoring System together with a sleep log | One week before intervention and one week after intervention (i.e., pre and post-test) |
| Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Trauma Questionnaire | About 10 minutes (only at pre-test) | |
| Iodine (test 1) | Urin | About 2-3 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sand Ridge Secure Treatment Center | Mauston | Wisconsin | 53948 | United States |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Pre and post-test design
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Double blind
| Placebo |
| Dietary Supplement |
120 mg olive oil |
|
| About 8-10 minutes (at both pre and post-test) |
| Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months) | Computerized cognitive task | About 10-15 minutes (at bot pre and post-test) |
| Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months) | Computerized cognitive task | About 10-15 minutes (at both pre and post test) |
| Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months) | Computerized cognitive task | About 15-20 minutes (at both pre and post test) |
| Change in heart rate variability from pre-test (baseline) to post-test (after 4 months) | 5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test) |
| About 5-10 minutes (at both pre and post-test) |
| Houston Non-Exercise Questionnaire | The log consists of weekly recording of various activity levels. | The physical activity log will be filled out weekly over the course of the study period (i.e., 24 -28 weeks) and estimated time per week is 10 minutes. |
| Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months) | About 10 minutes (at both pre and post-test) |
| Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months) | About 5 minutes (at both pre and post-test) |
| Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months) | About 5-10 minutes (at both pre and post-test) |
| Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months) | About 5-10 minutes (at both pre and post-test) |
| Iodine (test 2) |
Urin |
| About 2-3 minutes |