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

NCT02521012 | Active Not Recruiting

• 1 other identifier: KUH5703453
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Depression; Depressive Disorder

Keywords

Depression; Depressive symptoms; Vitamin D; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Beck Depression Inventory (BDI) scores

  0, 3, 6, 18 months

Study Arms (2)

Vitamin D 10 micrograms

ACTIVE COMPARATOR

Vitamin D supplementation 10 micrograms/day given to depressed individuals, defined as "reference"

Dietary Supplement: Vitamin D 10 micrograms

Vitamin D 100 micrograms

EXPERIMENTAL

Vitamin D supplementation 100 micrograms/day given to depressed individuals

Dietary Supplement: Vitamin D 100 micrograms

Interventions

Vitamin D 10 micrograms DIETARY_SUPPLEMENT

Vitamin D supplementations of 10 micrograms/day will be given to depressed individuals for three months

Vitamin D 10 micrograms

Vitamin D 100 micrograms DIETARY_SUPPLEMENT

Vitamin D supplementations of 100 micrograms/day will be given to depressed individuals for three months

Vitamin D 100 micrograms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Welbeing Servivces County of North Savo, Kuopio University Hospital, Department of Psychiatry

Kuopio, Finland

Location

MeSH Terms

Conditions

Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Maarit Pakarinen, MD, PhD

  Clinical lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: November 1, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FI (1)