Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression (D3-vit-dep)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Region Syddanmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Region Syddanmark
ClinicalTrials.gov Identifier:
NCT01390662
First received: July 5, 2011
Last updated: March 27, 2012
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Depression
Dietary Supplement: Vitamin D3
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

Resource links provided by NLM:


Further study details as provided by Region Syddanmark:

Primary Outcome Measures:
  • Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Hamilton-17 at week 24


Secondary Outcome Measures:
  • WHO-Five Well-being Index (WHO-5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in WHO-five at week 24


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3
one tablet of vitamin D3 (70µg) per day for 24 weeks.
Dietary Supplement: Vitamin D3
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
Placebo Comparator: placebo
one tablet of sugar pill per day for 24 weeks.
Dietary Supplement: placebo
one tablet of sugar pill pr. day, for 24 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390662

Contacts
Contact: Connie T Nielsen, PhD +4579182947 connie.thuroee.nielsen@psyk.regionsyddanmark.dk
Contact: Anne-Lene Kjeldmann +4579182947 anne-lene.kjeldmann@psyk.regionsyddanmark.dk

Locations
Denmark
Mental Health Services Esbjerg Recruiting
Esbjerg, Denmark, DK-6715
Contact: Connie T Nielsen, PhD    +4579182947    connie.thuroee.nielsen@psyk.regionsyddanmark.dk   
Principal Investigator: Connie T Nielsen, PhD         
Mental Health Services, Odense Recruiting
Odense, Denmark, Dk-5000
Contact: Tomas Toft, Ph.D    +4565413300    tomas.toft@psyk.regionsyddanmark.dk   
Principal Investigator: Tomas Toft, PhD         
Mental Health Services Svendborg Recruiting
Svendborg, Denmark, DK-5700
Contact: Erik Dahl, MD    63201051    Erik.dahl@psyk.regionsyddanmark.dk   
Principal Investigator: Erik Dahl, MD         
Sponsors and Collaborators
Region Syddanmark
Investigators
Study Chair: Connie T Nielsen, PhD Mental Health Services Esbjerg
Principal Investigator: Erik Dahl, MD Mental Health Services Svendborg
Principal Investigator: Tomas toft, PhD Mental Health Services Odense
  More Information

No publications provided

Responsible Party: Connie Thuroee Nielsen, consultant,PhD, Mental Health Services Esbjerg
ClinicalTrials.gov Identifier: NCT01390662     History of Changes
Other Study ID Numbers: 26992, 2010-023531-42
Study First Received: July 5, 2011
Last Updated: March 27, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Region Syddanmark:
serum 25-hydroxyvitamin d,vitamin D supplement, depression,
parathyroid hormone

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014