Key Nutrients and Mental Health
- Conditions
- Mental Health Impairment
- Interventions
- Dietary Supplement: Vitamin DDietary Supplement: Placebo
- Registration Number
- NCT03336125
- Lead Sponsor
- University of Bergen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 86
- Patients with intelligence quotient > 70 will be invited.
- Patients with intelligence quotient <70 will be excluded.
- Patients already taking vitamin D.
- Patients with psychotic disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D group Vitamin D Intervention is vitamin D supplement Control group Placebo Placebo capsule contains olive oil
- Primary Outcome Measures
Name Time Method Change in total cholesterol from pre-test (baseline) to post-test (after 4 months) Time for blood sample: about 10-15 minutes (at both pre and post test) Measured from blood sample
Change in triglycerides from pre-test (baseline) to post-test (after 4 months) Time for blood sample: about 10-15 minutes (at both pre and post-test) Measured from blood sample
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) Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months) Time for blood sample: about 10-15 minutes (at both pre and post test) Measured from blood sample
Change in serotonin from pre-test (baseline) to post-test (after 4 months) Time for blood sample: about 10-15 minutes (at both pre and post test) Measured form blood sample
Change in cortisol from pre-test (baseline) to post-test (after 4 months) 7 samples over 24 hours (at both pre and post-test) Saliva
Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months) About 8-10 minutes (at both pre and post-test) Computerized cognitive task
Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months) About 10-15 minutes (at bot pre and post-test) Computerized cognitive task
Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months) About 10-15 minutes (at both pre and post test) Computerized cognitive task
Change in lipoproteins from pre-test (baseline) to post-test (after 4 months) Time for blood sample: about 10-15 minutes (at both pre and post test) Measured from blood sample
Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months) About 15-20 minutes (at both pre and post test) Computerized cognitive task
- Secondary Outcome Measures
Name Time Method Change in sleep from pre-test (baseline) to post-test (after 4 months) One week before intervention and one week after intervention (i.e., pre and post-test) Measured by Ambulatory Monitoring System together with a sleep log
Houston Non-Exercise Questionnaire 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. The log consists of weekly recording of various activity levels.
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) 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) 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)
Trial Locations
- Locations (1)
Sand Ridge Secure Treatment Center
🇺🇸Mauston, Wisconsin, United States