NCT03336125

Key Nutrients and Mental Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mental Health Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Vitamin D (40µg/day) will be compared with placebo
DIETARY_SUPPLEMENT	Placebo	120 mg olive oil

Timeline

• Start date: 2017-11-17
• Primary completion: 2018-05-22
• Completion: 2018-05-22
• First posted: 2017-11-08
• Last updated: 2019-06-28

Locations

1 site across 1 country: United States