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

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D3
placebo
Sponsored by
Region Syddanmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Services EsbjergRecruiting
  • Mental Health Services, OdenseRecruiting
  • Mental Health Services SvendborgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3

placebo

Arm Description

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

one tablet of sugar pill per day for 24 weeks.

Outcomes

Primary Outcome Measures

Hamilton 17 item scale (Hamilton-17)
Change from baseline in Hamilton-17 at week 24

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2011
Last Updated
March 27, 2012
Sponsor
Region Syddanmark
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1. Study Identification

Unique Protocol Identification Number
NCT01390662
Brief Title
Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
Acronym
D3-vit-dep
Official Title
Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Region Syddanmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
one tablet of vitamin D3 (70µg) per day for 24 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one tablet of sugar pill per day for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
one tablet of sugar pill pr. day, for 24 weeks.
Primary Outcome Measure Information:
Title
Hamilton 17 item scale (Hamilton-17)
Description
Change from baseline in Hamilton-17 at week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
WHO-Five Well-being Index (WHO-5)
Description
Change from baseline in WHO-five at week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie T Nielsen, PhD
Phone
+4579182947
Email
connie.thuroee.nielsen@psyk.regionsyddanmark.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Lene Kjeldmann
Phone
+4579182947
Email
anne-lene.kjeldmann@psyk.regionsyddanmark.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie T Nielsen, PhD
Organizational Affiliation
Mental Health Services Esbjerg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erik Dahl, MD
Organizational Affiliation
Mental Health Services Svendborg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomas toft, PhD
Organizational Affiliation
Mental Health Services Odense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Services Esbjerg
City
Esbjerg
ZIP/Postal Code
DK-6715
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie T Nielsen, PhD
Phone
+4579182947
Email
connie.thuroee.nielsen@psyk.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Connie T Nielsen, PhD
Facility Name
Mental Health Services, Odense
City
Odense
ZIP/Postal Code
Dk-5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Toft, Ph.D
Phone
+4565413300
Email
tomas.toft@psyk.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Tomas Toft, PhD
Facility Name
Mental Health Services Svendborg
City
Svendborg
ZIP/Postal Code
DK-5700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Dahl, MD
Phone
63201051
Email
Erik.dahl@psyk.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Erik Dahl, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30944021
Citation
Hansen JP, Pareek M, Hvolby A, Schmedes A, Toft T, Dahl E, Nielsen CT. Vitamin D3 supplementation and treatment outcomes in patients with depression (D3-vit-dep). BMC Res Notes. 2019 Apr 3;12(1):203. doi: 10.1186/s13104-019-4218-z.
Results Reference
derived

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Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

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