Back to resultsActive Vitamin D Effect on Left Ventricular Hypertrophy
Primary Purpose
Chronic Kidney Disease, Secondary Hyperparathyroidism, Left Ventricular Hypertrophy
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Alfacalcidiol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD 3-4
Eligibility Criteria
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
Sites / Locations
- Department of Renal Medicne C, Skejby Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Given alfacalcidiol. Dose adjusted after PTH level
The untreated arm
Outcomes
Primary Outcome Measures
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
Secondary Outcome Measures
Changes in the activity of the renin-angiotensin system
Changes in left ventricular function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00175149
Brief Title
Active Vitamin D Effect on Left Ventricular Hypertrophy
Official Title
The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Ivarsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism, Left Ventricular Hypertrophy
Keywords
CKD 3-4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Given alfacalcidiol. Dose adjusted after PTH level
Arm Title
2
Arm Type
No Intervention
Arm Description
The untreated arm
Intervention Type
Drug
Intervention Name(s)
Alfacalcidiol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Changes in the activity of the renin-angiotensin system
Time Frame
6 month
Title
Changes in left ventricular function
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ivarsen, MD, PhD
Organizational Affiliation
Deparment of Renam Medicine C, Skejby Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Ivarsen, MD, PhD
Organizational Affiliation
Deparment of Renal Medicine C, Skejby Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Renal Medicne C, Skejby Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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Active Vitamin D Effect on Left Ventricular Hypertrophy
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