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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 478 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 6 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 6 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.
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 478 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 6years. 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 6 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Welbeing Servivces County of North Savo, Kuopio University Hospital, Department of Psychiatry
Kuopio, Finland
Start Date
November 1, 2015
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
September 19, 2025
319
ACTUAL participants
Vitamin D 10 micrograms
DIETARY_SUPPLEMENT
Vitamin D 100 micrograms
DIETARY_SUPPLEMENT
Lead Sponsor
Kuopio University Hospital
NCT07115329
NCT07360600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06793397