Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.

Detailed Description
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Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D]. At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3. New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS. In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression. The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes. The study is carried out in Mental Health Services in the Region of Southern Denmark for 24 weeks and offered to patients being treated for depression (treatment as usual) plus 70μg vitamin D3 or placebo.

Official Title
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Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria clinical diagnosis unipolar depression Exclusion Criteria: clinical diagnosis sarcoidoses tuberculosis bipolar affective disorder schizophrenia hypercalcemia hyperphosphatemia electroconvulsive treatment for the last 6 months primary diagnosis addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3<br>one tablet of vitamin D3 (70µg) per day for 24 weeks. | Dietary Supplement: Vitamin D3<br>* one tablet of vitamin D3 70 µg pr. day, for 24 weeks.<br>|
| Placebo Comparator: placebo<br>one tablet of sugar pill per day for 24 weeks. | Dietary Supplement: placebo<br>* one tablet of sugar pill pr. day, for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton 17 item scale (Hamilton-17) | Change from baseline in Hamilton-17 at week 24 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO-Five Well-being Index (WHO-5) | Change from baseline in WHO-five at week 24 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone