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NCT00175149 Clinical Trial

Active Vitamin D Effect on Left Ventricular Hypertrophy

Chronic Kidney Disease Clinical Trial

Official title:
The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00175149
Other study ID # EX 0203 DK
Secondary ID
Status Terminated
Phase Phase 4
First received September 11, 2005
Last updated December 6, 2015
Start date January 2002
Est. completion date December 2008

Study information
Verified date December 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Chronic kidney disease (S-creatinin > 150 and < 600 mikroM)

- Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay)

- Stable blood pressure during the last 6 months (less than (160/95)

- B-hemoglobin > 6 mmol/l

- EKG with sinus rhythm and no sign of Q-wave infarction

- Expected follow up 6 month

Exclusion Criteria:

- Pregnancy

- Kidney transplantation

- Malignant disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alfacalcidiol
Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.

Locations
Country Name City State
Denmark Department of Renal Medicne C, Skejby Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Per Ivarsen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of dihydroxycholecalciferol on left ventricular hypertrophy 6 month No
Secondary Changes in the activity of the renin-angiotensin system 6 month No
Secondary Changes in left ventricular function 6 month No
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