Impact of Vitamin D on Endothelial Function and Blood Bio... | NCT02005718

Studies
Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD

NCT02005718

Sponsor

St George's, University of London

Status

Completed

Last Update Posted

Dec 9, 2013Estimated

Enrollment

36Actual

Phase

Phase 3

Conditions

CKd Patients With Stage 3 and 4

Interventions

Cholecalciferol

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 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

Jun 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Dec 3, 2013

First Submission Date that Met QC Criteria

Dec 3, 2013

First Posted Date

Dec 9, 2013Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Experimental	Cholecalciferol 300,000 twice	Drug: Cholecalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug		Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flow mediated dilation		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
CD28 null cell frequency		16 weeks
Blood biomarkers of endothelial function and inflammation		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CKD 3-4 Age 18-80

Exclusion Criteria:

Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Debasish Banerjee	St Georges	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24646518	Derived	Chitalia N, Ismail T, Tooth L, Boa F, Hampson G, Goldsmith D, Kaski JC, Banerjee D. Impact of vitamin D supplementation on arterial vasomotion, stiffness and endothelial biomarkers in chronic kidney disease patients. PLoS One. 2014 Mar 19;9(3):e91363. doi: 10.1371/journal.pone.0091363. eCollection 2014.

Type	Date	Date Unknown
Release	Apr 19, 2016
Reset	May 25, 2016

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