Key Nutrients and Mental Health

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).

Study Overview

• Status: Completed
• Conditions: Mental Health Impairment
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Mauston, Wisconsin, United States, 53948
      • Sand Ridge Secure Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Trauma Questionnaire		About 10 minutes (only at pre-test)
Iodine (test 1)	Urin	About 2-3 minutes
Iodine (test 2)	Urin	About 2-3 minutes

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Haukeland University Hospital; Wisconsin Department of Health and Family Services; National Institute of Nutrition and Seafood Research, Norway

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2017
• Primary Completion (ACTUAL): May 22, 2018
• Study Completion (ACTUAL): May 22, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (ACTUAL): November 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 983 974 724

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No