Oral Alfacalcidol and Coronary Artery Calcification in Pr... | NCT01364688

Studies
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

NCT01364688

Sponsor

Ramathibodi Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2011Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Vascular Calcification

Interventions

oral alfacalcidol
no drug

Countries

Thailand

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 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

May 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

May 31, 2011

First Posted Date

Jun 2, 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 31, 2011

Last Update Posted Date

Jun 2, 2011Estimated

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

Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Detailed Description

Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	oral alfacalcidol	Drug: oral alfacalcidol
Control	No Intervention	No drug	Drug: no drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral alfacalcidol	Drug	Oral alfacalcidol 0.5 microgram per day	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Coronary Artery Calcification		6 months and 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
PTH above the upper limit of normal
serum calcium and phosphate below the upper limit of normal

Exclusion Criteria:

changes in GFR>15% during the past 3 months
receive elemental calcium>500 mg/day
currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate

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

Name	Role	Phone	Extension	Email
Sinee Disthabanchong, MD	Contact	+6622011116		tesdb@mahidol.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Recruiting	Phayathai	Bangkok	10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D061205	Vascular Calcification

Ancestor Terms

ID	Term
D002114	Calcinosis
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008088	alfacalcidol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided