Key Nutrients and Mental Health

Mental Health Impairment Clinical Trial

Official title:

Key Nutrients and Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336125
• Other study ID #: 983 974 724
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: June 2019
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Impairment

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D (40µg/day) will be compared with placebo
• Placebo
120 mg olive oil

Locations

Country	Name	City	State
United States	Sand Ridge Secure Treatment Center	Mauston	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital, National Institute of Nutrition and Seafood Research, Norway, Wisconsin Department of Health and Family Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Childhood Trauma Questionnaire		About 10 minutes (only at pre-test)
Other	Iodine (test 1)	Urin	About 2-3 minutes
Other	Iodine (test 2)	Urin	About 2-3 minutes
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)