Key Nutrients and Mental Health

June 26, 2019 updated by: Anita Lill Hansen, University of Bergen
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Mauston, Wisconsin, United States, 53948
        • Sand Ridge Secure Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Vitamin D group
Intervention is vitamin D supplement
Dietary supplement: Vitamin D
Vitamin D (40µg/day) will be compared with placebo
PLACEBO_COMPARATOR: Control group
Placebo capsule contains olive oil
Dietary supplement: Placebo
120 mg olive oil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months)
Time Frame: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Time for blood sample: about 10-15 minutes (at both pre and post test)
Change in serotonin from pre-test (baseline) to post-test (after 4 months)
Time Frame: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured form blood sample
Time for blood sample: about 10-15 minutes (at both pre and post test)
Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)
Time Frame: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Time for blood sample: about 10-15 minutes (at both pre and post test)
Change in lipoproteins from pre-test (baseline) to post-test (after 4 months)
Time Frame: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Time for blood sample: about 10-15 minutes (at both pre and post test)
Change in triglycerides from pre-test (baseline) to post-test (after 4 months)
Time Frame: Time for blood sample: about 10-15 minutes (at both pre and post-test)
Measured from blood sample
Time for blood sample: about 10-15 minutes (at both pre and post-test)
Change in cortisol from pre-test (baseline) to post-test (after 4 months)
Time Frame: 7 samples over 24 hours (at both pre and post-test)
Saliva
7 samples over 24 hours (at both pre and post-test)
Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 8-10 minutes (at both pre and post-test)
Computerized cognitive task
About 8-10 minutes (at both pre and post-test)
Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 10-15 minutes (at bot pre and post-test)
Computerized cognitive task
About 10-15 minutes (at bot pre and post-test)
Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 10-15 minutes (at both pre and post test)
Computerized cognitive task
About 10-15 minutes (at both pre and post test)
Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 15-20 minutes (at both pre and post test)
Computerized cognitive task
About 15-20 minutes (at both pre and post test)
Change in heart rate variability from pre-test (baseline) to post-test (after 4 months)
Time Frame: 5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test)
5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in sleep from pre-test (baseline) to post-test (after 4 months)
Time Frame: One week before intervention and one week after intervention (i.e., pre and post-test)
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)
Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 5-10 minutes (at both pre and post-test)
About 5-10 minutes (at both pre and post-test)
Houston Non-Exercise Questionnaire
Time Frame: 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.
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.
Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 10 minutes (at both pre and post-test)
About 10 minutes (at both pre and post-test)
Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 5 minutes (at both pre and post-test)
About 5 minutes (at both pre and post-test)
Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 5-10 minutes (at both pre and post-test)
About 5-10 minutes (at both pre and post-test)
Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months)
Time Frame: About 5-10 minutes (at both pre and post-test)
About 5-10 minutes (at both pre and post-test)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Childhood Trauma Questionnaire
Time Frame: About 10 minutes (only at pre-test)
About 10 minutes (only at pre-test)
Iodine (test 1)
Time Frame: About 2-3 minutes
Urin
About 2-3 minutes
Iodine (test 2)
Time Frame: About 2-3 minutes
Urin
About 2-3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Haukeland University Hospital
Wisconsin Department of Health and Family Services
National Institute of Nutrition and Seafood Research, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 983 974 724

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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