Key Nutrients and Mental Health

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Key Nutrients and Mental Health

Conditions
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Mental Health Impairment

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with intelligence quotient > 70 will be invited. Exclusion Criteria: Patients with intelligence quotient <70 will be excluded. Patients already taking vitamin D. Patients with psychotic disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pre and post-test design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br>Intervention is vitamin D supplement | Dietary Supplement: Vitamin D<br>* Vitamin D (40µg/day) will be compared with placebo<br>|
| Placebo Comparator: Control group<br>Placebo capsule contains olive oil | Dietary Supplement: Placebo<br>* 120 mg olive oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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) |