Key Nutrients and Mental Health
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vitamin D group Intervention is vitamin D supplement |
Dietary Supplement: Vitamin D
Vitamin D (40µg/day) will be compared with placebo
|
| Placebo Comparator: Control group Placebo capsule contains olive oil |
Dietary Supplement: Placebo
120 mg olive oil
|
Outcome Measures
Primary Outcome Measures
- 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 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 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 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 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 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
- 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
- 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
- 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 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 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)]
Other Outcome Measures
- Childhood Trauma Questionnaire [About 10 minutes (only at pre-test)]
- Iodine (test 1) [About 2-3 minutes]
Urin
- Iodine (test 2) [About 2-3 minutes]
Urin
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sand Ridge Secure Treatment Center | Mauston | Wisconsin | United States | 53948 |
Sponsors and Collaborators
- University of Bergen
- Wisconsin Department of Health and Family Services
- Haukeland University Hospital
- National Institute of Nutrition and Seafood Research, Norway
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 983 974 724