Key Nutrients and Mental Health

University of Bergen

Status: Completed

Conditions: Mental Health Impairment

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03336125

983 974 724

Details and patient eligibility

About

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).

Full 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.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

Intervention is vitamin D supplement

Treatment:

Dietary Supplement: Vitamin D

Control group

Placebo Comparator group

Description:

Placebo capsule contains olive oil

Treatment:

Dietary Supplement: Placebo