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

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ClinicalTrials.gov Identifier: NCT01390662
Recruitment Status : Unknown
Verified July 2011 by Region Syddanmark.
Recruitment status was:  Recruiting
First Posted : July 11, 2011
Last Update Posted : March 28, 2012
Sponsor:
Information provided by:
Region Syddanmark

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Vitamin D3 Dietary Supplement: placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
Study Start Date : March 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton 17 item scale (Hamilton-17) [ Time Frame: 24 weeks ]
    Change from baseline in Hamilton-17 at week 24


Secondary Outcome Measures :
  1. WHO-Five Well-being Index (WHO-5) [ Time Frame: 24 weeks ]
    Change from baseline in WHO-five at week 24


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( EudraCT Number )
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: July 2011

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
Vitamins
Vitamin D
 Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents