Active Vitamin D Effect on Left Ventricular Hypertrophy

Phase 4

Terminated

• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Left Ventricular Hypertrophy
• Interventions: Drug: Alfacalcidiol

• Registration Number: NCT00175149
• Lead Sponsor: Per Ivarsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-15
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-06
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Alfacalcidiol	Given alfacalcidiol. Dose adjusted after PTH level

Primary Outcome Measures

Name	Time	Method
The effect of dihydroxycholecalciferol on left ventricular hypertrophy	6 month

Secondary Outcome Measures

Name	Time	Method
Changes in the activity of the renin-angiotensin system	6 month
Changes in left ventricular function	6 month

Trial Locations

Locations (1)

Department of Renal Medicne C, Skejby Hospital; 🇩🇰 Aarhus, Denmark