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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2025
  • participants needed
    3028
  • sponsor
    Kuopio University Hospital
Updated on 23 January 2021
psychosis
psychiatric disorder
antidepressants
scid
depressed mood
major depressive disorder
severe depression
recurrent depression

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 g/day) or high (100 g/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.

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 g/day) or high (100 g/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.

Details
Condition mood disorder, Endogenous depression, Depression, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Depressed, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, depressive disorder, depressed mood, miserable, depressive disorders
Treatment Vitamin D 10 micrograms, Vitamin D 100 micrograms
Clinical Study IdentifierNCT02521012
SponsorKuopio University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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