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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01364688
Other study ID # 25-05-2011
Secondary ID
Status Recruiting
Phase Phase 2
First received May 26, 2011
Last updated May 31, 2011
Start date May 2011
Est. completion date December 2012

Study information

Verified date May 2011
Source Ramathibodi Hospital
Contact Sinee Disthabanchong, MD
Phone +6622011116
Email tesdb@mahidol.ac.th
Is FDA regulated No
Health authority Thailand: Mahidol University
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
oral alfacalcidol
Oral alfacalcidol 0.5 microgram per day
no drug
no drug

Locations

Country Name City State
Thailand Faculty of Medicine, Ramathibodi Hospital, Mahidol University Phayathai Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Coronary Artery Calcification 6 months and 12 months No
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