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Follow-up Study With Clinical Vitamin D Supplementation Trial on Patients With Depression (DepFuD) (DepFuD)

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ClinicalTrials.gov Identifier: NCT02521012
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Heimo Viinamaki, Kuopio University Hospital

Brief Summary:

Depression affects 350 million people worldwide. In the light of the global disease burden statistics, the efficacy of current treatments for depression appears insufficient. Thus, research on novel treatment interventions and predictors for good treatment response are warranted. Earlier prospective follow-up studies and intervention studies suggest that several bio-psychosocial factors, including high serum concentrations of vitamin D, are related to better treatment outcomes. In this follow-up study with randomized clinical vitamin D supplementation trial on patients with depression, the investigators aim to

  1. clarify how a six-month intervention with vitamin D supplementation affects treatment response, recovery, and the biological pathways related to depression. This aims to finding potential sub-groups getting benefits from vitamin D supplementation. In addition, the investigators want to
  2. investigate and characterize factors related to recovery from depression and working ability in depression patients in the long-term. The investigators are especially interested in the bio-psychosocial factors and the aims include examining both the individual's positive resources.

The trial will start with a six-month double-blinded randomized controlled trial with vitamin D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic, unipolar depression, aged 18-65 years, who are referred to the recruitment sites for treatment for depression. The participants will be randomized to low (10 µg/day) or high (100 µg/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will continue during the intervention as needed. After six months of intervention, the participants will be followed up at 18 months and at 5 years.

Several measurements will be conducted during the intervention and follow-up period. Participants will fill a variety of clinical questionnaires and questionnaires with background information. All participants give blood samples for biomarker analyses at time points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.


Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Dietary Supplement: Vitamin D 10 micrograms Dietary Supplement: Vitamin D 100 micrograms Not Applicable

Detailed Description:

Depression affects 350 million people worldwide. In the light of the global disease burden statistics, the efficacy of current treatments for depression appears insufficient. Thus, research on novel treatment interventions and predictors for good treatment response are warranted. Earlier prospective follow-up studies and intervention studies suggest that several bio-psychosocial factors, including high serum concentrations of vitamin D, are related to better treatment outcomes.

In this follow-up study with randomized clinical vitamin D supplementation trial on patients with depression, the investigators aim to

  1. clarify how a six-month intervention with vitamin D supplementation affects treatment response, recovery, and the biological pathways related to depression. This aims to finding potential sub-groups getting benefits from vitamin D supplementation. In addition, the investigators want to
  2. investigate and characterize factors related to recovery from depression and working ability in depression patients in the long-term. The investigators are especially interested in the bio-psychosocial factors and the aims include examining both the individual's positive resources.

The trial will start with a six-month double-blinded randomized controlled trial with vitamin D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic, unipolar depression, aged 18-65 years, who are referred to the recruitment sites for treatment for depression. The participants will be randomized to low (10 µg/day) or high (100 µg/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will continue during the intervention as needed. After six months of intervention, the participants will be followed up at 18 months and at 5 years.

Several measurements will be conducted during the intervention and follow-up period. Participants will fill a variety of clinical questionnaires and questionnaires with background information. All participants give blood samples for biomarker analyses at time points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-up Study With Randomized Clinical Vitamin D Supplementation Trial on Patients With Depression (DepFuD)
Study Start Date : November 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D 10 micrograms
Vitamin D supplementation 10 micrograms/day given to depressed individuals, defined as "reference"
Dietary Supplement: Vitamin D 10 micrograms
Vitamin D supplementations of 10 micrograms/day will be given to depressed individuals for three months

Experimental: Vitamin D 100 micrograms
Vitamin D supplementation 100 micrograms/day given to depressed individuals
Dietary Supplement: Vitamin D 100 micrograms
Vitamin D supplementations of 100 micrograms/day will be given to depressed individuals for three months




Primary Outcome Measures :
  1. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores [ Time Frame: 0, 3 and 6 months ]
    We are interviewing the patients with depression with MADRS, which has been found to be a practical tool for assessing depressive symptoms in clinical trials. We are especially interest to see the change in scores during the intervention.


Secondary Outcome Measures :
  1. Change in Beck Depression Inventory (BDI) scores [ Time Frame: 0, 3, 6, 18 months ]
    Participants fill a 21-item Beck Depression Inventory questionnaire and total scores will be calculated. We are especially interested to see if the total scores changes during the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients referred to the recruitment sites for treatment for depression
  • mild, moderate or severe depression,
  • mild, moderate or severe episode of recurrent depression

Exclusion Criteria:

  • bipolar or psychotic depression
  • psychotic disorder
  • severe substance abuse
  • disabilities in senses that affect functioning and severely threat completing the trial
  • diseases that affect vitamin D metabolism (such as sarcoidosis, hypercalcemia, hypofunction of kidney)
  • pregnancy or lactation
  • current use of high dose vitamin D supplementation
  • current use of high dose calcium supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521012


Contacts
Contact: Heimo Viinamäki, Professor heimo.viinamaki@kuh.fi
Contact: Anu Ruusunen, PhD anu.ruusunen@kuh.fi

Locations
Finland
Kuopio University Hospital, Department of Psychiatry Recruiting
Kuopio, Finland
Contact: Ritva Von Koch    +358447174766    ritva.vonkoch@kuh.fi   
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Chair: Heimo Viinamaki, Professor Professor, Head of Department

Responsible Party: Heimo Viinamaki, Professor, Head of Department of Psychiatry, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02521012     History of Changes
Other Study ID Numbers: DepFuDKUH5703453
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Heimo Viinamaki, Kuopio University Hospital:
Depression
Depressive symptoms
Vitamin D
Intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents