Trial | NCT01390662  Report issue

Title

Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    150
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.
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 Started
Mar 31
2011
Primary Completion
May 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Mar 28
2012
Estimate

Dietary Supplement Vitamin D3

one tablet of vitamin D3 70 µg pr. day, for 24 weeks.

Dietary Supplement placebo

one tablet of sugar pill pr. day, for 24 weeks.

Vitamin D3 Active Comparator

one tablet of vitamin D3 (70µg) per day for 24 weeks.

placebo Placebo Comparator

one tablet of sugar pill per day for 24 weeks.

Criteria 

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
No Results Posted