Key Nutrients and Mental Health

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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