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

Depression Clinical Trial

— DepFuD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521012
• Other study ID #: DepFuDKUH5703453
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 2025

Study information

• Verified date: August 2019
• Source: Kuopio University Hospital
• Contact: Heimo Viinamäki, Professor
• Email: heimo.viinamaki[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3028
• Est. completion date: October 2025
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Vitamin D 10 micrograms
Vitamin D supplementations of 10 micrograms/day will be given to depressed individuals for three months
• Vitamin D 100 micrograms
Vitamin D supplementations of 100 micrograms/day will be given to depressed individuals for three months

Locations

Country	Name	City	State
Finland	Kuopio University Hospital, Department of Psychiatry	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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