Key Nutrients and Mental Health

NCT ID: NCT03336125

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-05-22

Brief Summary

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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

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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

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Mental Health Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pre and post-test design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Double blind

Study Groups

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Vitamin D group

Intervention is vitamin D supplement

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Control group

Placebo capsule contains olive oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

120 mg olive oil

Interventions

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Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

120 mg olive oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wisconsin Department of Health and Family Services

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

National Institute of Nutrition and Seafood Research, Norway

OTHER_GOV

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Anita Lill Hansen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sand Ridge Secure Treatment Center

Mauston, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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983 974 724

Identifier Type: -

Identifier Source: org_study_id

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