Can Vitamin D3 Supplementation Affect Treatment Outcomes... | NCT01390662

Studies
Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

NCT01390662

Sponsor

Region Syddanmark

Status

Unknown status

Last Update Posted

Mar 28, 2012Estimated

Enrollment

150Estimated

Phase

Phase 4

Conditions

Depression

Interventions

Vitamin D3
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-023531-42	EudraCT Number

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

May 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 5, 2011

First Submission Date that Met QC Criteria

Jul 8, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2012

Last Update Posted Date

Mar 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D3	Active Comparator	one tablet of vitamin D3 (70µg) per day for 24 weeks.	Dietary Supplement: Vitamin D3
placebo	Placebo Comparator	one tablet of sugar pill per day for 24 weeks.	Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3	Dietary Supplement	one tablet of vitamin D3 70 µg pr. day, for 24 weeks.	Vitamin D3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton 17 item scale (Hamilton-17)	Change from baseline in Hamilton-17 at week 24	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
WHO-Five Well-being Index (WHO-5)	Change from baseline in WHO-five at week 24	24 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Connie T Nielsen, PhD	Contact	+4579182947		connie.thuroee.nielsen@psyk.regionsyddanmark.dk
Anne-Lene Kjeldmann	Contact	+4579182947		anne-lene.kjeldmann@psyk.regionsyddanmark.dk

Overall Officials

Name	Affiliation	Role
Connie T Nielsen, PhD	Mental Health Services Esbjerg	Study Chair
Erik Dahl, MD	Mental Health Services Svendborg	Principal Investigator
Tomas toft, PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Services Esbjerg	Recruiting	Esbjerg		DK-6715	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30944021	Derived	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds