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Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01364688
Enrollment
80
Registered
2011-06-02
Start date
2011-05-31
Completion date
2012-12-31
Last updated
2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Calcification

Keywords

coronary calcification, vascular calcification, active vitamin D, alfacalcidol

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.

Interventions

DRUGoral alfacalcidol

Oral alfacalcidol 0.5 microgram per day

DRUGno drug

no drug

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Coronary Artery Calcification6 months and 12 months

Countries

Thailand

Contacts

Primary ContactSinee Disthabanchong, MD
tesdb@mahidol.ac.th+6622011116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026