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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
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D 10 micrograms | Active Comparator | Vitamin D supplementation 10 micrograms/day given to depressed individuals, defined as "reference" |
|
| Vitamin D 100 micrograms | Experimental | Vitamin D supplementation 100 micrograms/day given to depressed individuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D 10 micrograms | Dietary Supplement | Vitamin D supplementations of 10 micrograms/day will be given to depressed individuals for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Ã…sberg 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarit Pakarinen, MD, PhD | Clinical lecturer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Welbeing Servivces County of North Savo, Kuopio University Hospital, Department of Psychiatry | Kuopio | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41933624 | Derived | Mikola T, Lehto SM, Tolmunen T, Honkalampi K, Valkonen-Korhonen M, Laukkanen V, Pakarinen M, Koivumaa-Honkanen H, Ruusunen A. Effect of a six-month vitamin D supplementation on depressive symptoms in patients with major depressive episode (DepFuD): a double-blinded randomised controlled trial. J Affect Disord. 2026 Aug 1;406:121709. doi: 10.1016/j.jad.2026.121709. Epub 2026 Mar 31. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Vitamin D 100 micrograms | Dietary Supplement | Vitamin D supplementations of 100 micrograms/day will be given to depressed individuals for three months |
|