Key Nutrients and Mental Health

NCT03336125 | Completed

• 1 other identifier: 983 974 724
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Health Impairment

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• 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)

• 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.

• 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)

Other Outcomes (3)

• Childhood Trauma Questionnaire

  About 10 minutes (only at pre-test)

• Iodine (test 1)

  About 2-3 minutes

• Iodine (test 2)

  About 2-3 minutes

Study Arms (2)

Vitamin D group

EXPERIMENTAL

Intervention is vitamin D supplement

Dietary Supplement: Vitamin D

Control group

PLACEBO COMPARATOR

Placebo capsule contains olive oil

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Vitamin D group

Placebo DIETARY_SUPPLEMENT

120 mg olive oil

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intelligence quotient \> 70 will be invited.

You may not qualify if:

• Patients with intelligence quotient \<70 will be excluded.
• Patients already taking vitamin D.
• Patients with psychotic disorders.

Sponsors & Collaborators

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

Study Sites (1)

Sand Ridge Secure Treatment Center

Mauston, Wisconsin, 53948, United States

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre and post-test design

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 8, 2017
• Study Start: November 17, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

US (1)