Key Nutrients and Mental Health

Not Applicable

Completed

• Conditions: Mental Health Impairment

• 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.

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-08
• Study Start: 2017-11-17
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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