Vitamin D3 Supplementation in Dialysis Patients | NCT01312714

Studies
Vitamin D3 Supplementation in Dialysis Patients

NCT01312714

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 29, 2013Estimated

Enrollment

64Actual

Phase

Phase 2

Conditions

End-Stage Renal Disease

Interventions

Cholecalciferol
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

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Mar 9, 2011

First Submission Date that Met QC Criteria

Mar 9, 2011

First Posted Date

Mar 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

May 28, 2013

Last Update Posted Date

May 29, 2013Estimated

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

Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cholecalciferol	Active Comparator		Drug: Cholecalciferol
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	3 tablets of 1000 IU daily for 26 weeks	Cholecalciferol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of NT-proBNP		26 weeks

Secondary Outcomes

Measure	Description	Time Frame
Plasma concentration of ionized calcium		4 weeks
Plasma concentration of phosphate		4 weeks
Plasma concentration of PTH

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hemodialysis or peritoneal dialysis > 3 months

Exclusion Criteria:

Hypercalceamia
Cancer
Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, M.D., M.Sci.	Departments of Medical Research and Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departments of Medical Research and Medicine, Holstebro Hospital		Holstebro	Holstebro	7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24661355	Derived	Mose FH, Vase H, Larsen T, Kancir AS, Kosierkiewic R, Jonczy B, Hansen AB, Oczachowska-Kulik AE, Thomsen IM, Bech JN, Pedersen EB. Cardiovascular effects of cholecalciferol treatment in dialysis patients--a randomized controlled trial. BMC Nephrol. 2014 Mar 24;15:50. doi: 10.1186/1471-2369-15-50.

ID	Term
D007676	Kidney Failure, Chronic
D014808	Vitamin D Deficiency

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

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