Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

Phase 4

• Conditions: Depression
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT01390662
• Lead Sponsor: Region Syddanmark

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-11
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28
• Primary Completion: 2012-05
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

• clinical diagnosis sarcoidoses
• tuberculosis
• bipolar affective disorder
• schizophrenia
• hypercalcemia
• hyperphosphatemia
• electroconvulsive treatment for the last 6 months
• primary diagnosis addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	one tablet of sugar pill per day for 24 weeks.
Vitamin D3	Vitamin D3	one tablet of vitamin D3 (70µg) per day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Hamilton 17 item scale (Hamilton-17)	24 weeks	Change from baseline in Hamilton-17 at week 24

Secondary Outcome Measures

Name	Time	Method
WHO-Five Well-being Index (WHO-5)	24 weeks	Change from baseline in WHO-five at week 24

Trial Locations

Locations (3)

Mental Health Services Esbjerg; 🇩🇰 Esbjerg, Denmark

Mental Health Services Svendborg; 🇩🇰 Svendborg, Denmark

Mental Health Services, Odense; 🇩🇰 Odense, Denmark