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CompletedNCT03336125Updated Jun 28, 2019

Key Nutrients and Mental Health

An interventional study of Vitamin D and Placebo in Mental Health Impairment, sponsored by University of Bergen. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by University of Bergen · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Mental Health Impairment
03

In context

Lead sponsor

University of Bergen is the lead sponsor of 143 studies on the registry; 19 are open to participants now.

Browse University of Bergen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with intelligence quotient > 70 will be invited.

Exclusion criteria

Exclusion Criteria:

  • Patients with intelligence quotient \<70 will be excluded.
  • Patients already taking vitamin D.
  • Patients with psychotic disorders.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Vitamin D group

    Intervention is vitamin D supplement

    Dietary Supplement: Vitamin D

  • Placebo comparator
    Control group

    Placebo capsule contains olive oil

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin D

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

  • Dietary supplementPlacebo

    120 mg olive oil

06

What researchers measure

Primary outcomes

  1. Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months)

    Measured from blood sample

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

  2. Change in serotonin from pre-test (baseline) to post-test (after 4 months)

    Measured form blood sample

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

  3. Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)

    Measured from blood sample

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

  4. Change in lipoproteins from pre-test (baseline) to post-test (after 4 months)

    Measured from blood sample

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post test)

  5. Change in triglycerides from pre-test (baseline) to post-test (after 4 months)

    Measured from blood sample

    Time frame: Time for blood sample: about 10-15 minutes (at both pre and post-test)

  6. Change in cortisol from pre-test (baseline) to post-test (after 4 months)

    Saliva

    Time frame: 7 samples over 24 hours (at both pre and post-test)

  7. Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months)

    Computerized cognitive task

    Time frame: About 8-10 minutes (at both pre and post-test)

  8. Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months)

    Computerized cognitive task

    Time frame: About 10-15 minutes (at bot pre and post-test)

  9. Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months)

    Computerized cognitive task

    Time frame: About 10-15 minutes (at both pre and post test)

  10. Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months)

    Computerized cognitive task

    Time frame: About 15-20 minutes (at both pre and post test)

  11. 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)

Secondary outcomes

  1. Change in sleep from pre-test (baseline) to post-test (after 4 months)

    Measured by Ambulatory Monitoring System together with a sleep log

    Time frame: One week before intervention and one week after intervention (i.e., pre and post-test)

  2. 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)

  3. Houston Non-Exercise Questionnaire

    The log consists of weekly recording of various activity levels.

    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.

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Other outcomes

  1. Childhood Trauma Questionnaire

    Time frame: About 10 minutes (only at pre-test)

  2. Iodine (test 1)

    Urin

    Time frame: About 2-3 minutes

  3. Iodine (test 2)

    Urin

    Time frame: About 2-3 minutes

07

Study locations

1 site
  • Sand Ridge Secure Treatment Center
    Mauston, Wisconsin 53948, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in May 2018, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 8, 2017
StartActual
Nov 17, 2017
Primary completionActual
May 22, 2018
CompletionActual
May 22, 2018
Last update
Jun 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03336125
Lead sponsor
University of Bergen
Collaborators
Wisconsin Department of Health and Family Services, Haukeland University Hospital, National Institute of Nutrition and Seafood Research, Norway
Responsible party
Anita Lill Hansen (Professor, University of Bergen) — Principal investigator
First posted
Nov 8, 2017
Start date
Nov 17, 2017
Primary completion
May 22, 2018
Completion
May 22, 2018
Last update
Jun 28, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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