Skip to main content
OpenTrials
Completed

NCT Number: NCT03336125

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Health Impairment

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sand Ridge Secure Treatment Center

Mauston, Wisconsin, 53948, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D (40µg/day) will be compared with placebo

Placebo

Dietary Supplement

120 mg olive oil

Primary outcomes

  1. Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months)

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

    Measured from blood sample

  2. Change in serotonin from pre-test (baseline) to post-test (after 4 months)

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

    Measured form blood sample

  3. Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

    Measured from blood sample

  4. Change in lipoproteins from pre-test (baseline) to post-test (after 4 months)

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

    Measured from blood sample

  5. Change in triglycerides from pre-test (baseline) to post-test (after 4 months)

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post-test)

    Measured from blood sample

  6. Change in cortisol from pre-test (baseline) to post-test (after 4 months)

    Time frame: 7 samples over 24 hours (at both pre and post-test)

    Saliva

  7. Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 8-10 minutes (at both pre and post-test)

    Computerized cognitive task

  8. Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 10-15 minutes (at bot pre and post-test)

    Computerized cognitive task

  9. Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 10-15 minutes (at both pre and post test)

    Computerized cognitive task

  10. Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 15-20 minutes (at both pre and post test)

    Computerized cognitive task

  11. Change in heart rate variability from pre-test (baseline) to post-test (after 4 months)

    Time frame: 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

  1. Change in sleep from pre-test (baseline) to post-test (after 4 months)

    Time frame: 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

  2. Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 5-10 minutes (at both pre and post-test)

  3. Houston Non-Exercise Questionnaire

    Time frame: 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.

  4. Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 10 minutes (at both pre and post-test)

  5. Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 5 minutes (at both pre and post-test)

  6. Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 5-10 minutes (at both pre and post-test)

  7. Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months)

    Time frame: About 5-10 minutes (at both pre and post-test)

Other outcomes

  1. Childhood Trauma Questionnaire

    Time frame: About 10 minutes (only at pre-test)

  2. Iodine (test 1)

    Time frame: About 2-3 minutes

    Urin

  3. Iodine (test 2)

    Time frame: About 2-3 minutes

    Urin

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital
  • National Institute of Nutrition and Seafood Research, Norway
  • Wisconsin Department of Health and Family Services

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2017
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.