Active Vitamin D Effect on Left Ventricular Hypertrophy

December 6, 2015 updated by: Per Ivarsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Renal Medicne C, Skejby Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Given alfacalcidiol. Dose adjusted after PTH level
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.
No Intervention: 2
The untreated arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the activity of the renin-angiotensin system
Time Frame: 6 month
6 month
Changes in left ventricular function
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Ivarsen

Investigators

  • Principal Investigator: Per Ivarsen, MD, PhD, Deparment of Renam Medicine C, Skejby Hospital
  • Principal Investigator: Per Ivarsen, MD, PhD, Deparment of Renal Medicine C, Skejby Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 6, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX 0203 DK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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