Clinical trial NCT03336125: Key Nutrients and Mental Health
Official title: Key Nutrients and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Impairment
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Wisconsin Department of Health and Family Services
name: Haukeland University Hospital
name: National Institute of Nutrition and Seafood Research, Norway
First posted: 2017-11-08
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre and post-test design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months)
timeFrame: Time for blood sample: about 10-15 minutes (at both pre and post test)
measure: Change in serotonin from pre-test (baseline) to post-test (after 4 months)
timeFrame: Time for blood sample: about 10-15 minutes (at both pre and post test)
measure: Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)
timeFrame: Time for blood sample: about 10-15 minutes (at both pre and post test)
measure: Change in lipoproteins from pre-test (baseline) to post-test (after 4 months)
timeFrame: Time for blood sample: about 10-15 minutes (at both pre and post test)
measure: Change in triglycerides from pre-test (baseline) to post-test (after 4 months)
timeFrame: Time for blood sample: about 10-15 minutes (at both pre and post-test)
measure: Change in cortisol from pre-test (baseline) to post-test (after 4 months)
timeFrame: 7 samples over 24 hours (at both pre and post-test)
measure: Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 8-10 minutes (at both pre and post-test)
measure: Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 10-15 minutes (at bot pre and post-test)
measure: Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 10-15 minutes (at both pre and post test)
measure: Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 15-20 minutes (at both pre and post test)
measure: Change in heart rate variability from pre-test (baseline) to post-test (after 4 months)
timeFrame: 5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test)
Secondary outcomes:
measure: Change in sleep from pre-test (baseline) to post-test (after 4 months)
timeFrame: One week before intervention and one week after intervention (i.e., pre and post-test)
measure: Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 5-10 minutes (at both pre and post-test)
measure: Houston Non-Exercise Questionnaire
timeFrame: 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.
measure: Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 10 minutes (at both pre and post-test)
measure: Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 5 minutes (at both pre and post-test)
measure: Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 5-10 minutes (at both pre and post-test)
measure: Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months)
timeFrame: About 5-10 minutes (at both pre and post-test)
Other outcomes:
measure: Childhood Trauma Questionnaire
timeFrame: About 10 minutes (only at pre-test)
measure: Iodine (test 1)
timeFrame: About 2-3 minutes
measure: Iodine (test 2)
timeFrame: About 2-3 minutes
Locations:
city: Mauston
country: United States
facility: Sand Ridge Secure Treatment Center
state: Wisconsin
Study officials:
References: