Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

NCT ID: NCT01364688

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vascular Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

oral alfacalcidol

Group Type EXPERIMENTAL

oral alfacalcidol

Intervention Type DRUG

Oral alfacalcidol 0.5 microgram per day

Control

No drug

Group Type NO_INTERVENTION

no drug

Intervention Type DRUG

no drug

Interventions

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oral alfacalcidol

Oral alfacalcidol 0.5 microgram per day

Intervention Type DRUG

no drug

no drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

Locations

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Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Phayathai, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Sinee Disthabanchong, MD

Role: CONTACT

+6622011116

Facility Contacts

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Sinee Disthabanchong, MD

Role: primary

+662011116

Other Identifiers

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25-05-2011

Identifier Type: -

Identifier Source: org_study_id

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