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

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

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 Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Depression
• Intervention / Treatment: Dietary supplement: Vitamin D 10 micrograms; Dietary supplement: Vitamin D 100 micrograms

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
• Enrollment (Anticipated): 3028
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heimo Viinamäki, Professor; Email: heimo.viinamaki@kuh.fi
• Study Contact Backup: Name: Anu Ruusunen, PhD; Email: anu.ruusunen@kuh.fi

Study Locations

• Finland
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital, Department of Psychiatry
    • Contact: Ritva Von Koch; Phone Number: +358447174766; Email: ritva.vonkoch@kuh.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores	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.	0, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Depression Inventory (BDI) scores	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.	0, 3, 6, 18 months

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Investigators: Study Chair: Heimo Viinamaki, Professor, Professor, Head of Department

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Vitamin D; Intervention; Depressive symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: DepFuDKUH5703453