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Active Vitamin D Effect on Left Ventricular Hypertrophy

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00175149
First Posted: September 15, 2005
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Ivarsen, Aarhus University Hospital
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Left Ventricular Hypertrophy Drug: Alfacalcidiol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction

Further study details as provided by Per Ivarsen, Aarhus University Hospital:

Primary Outcome Measures:
  • The effect of dihydroxycholecalciferol on left ventricular hypertrophy [ Time Frame: 6 month ]

Secondary Outcome Measures:
  • Changes in the activity of the renin-angiotensin system [ Time Frame: 6 month ]
  • Changes in left ventricular function [ Time Frame: 6 month ]

Enrollment: 24
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175149


Locations
Denmark
Department of Renal Medicne C, Skejby Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
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
  More Information

Responsible Party: Per Ivarsen, Consultant, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00175149     History of Changes
Other Study ID Numbers: EX 0203 DK
First Submitted: September 11, 2005
First Posted: September 15, 2005
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Per Ivarsen, Aarhus University Hospital:
CKD 3-4

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hypertrophy
Hyperparathyroidism, Secondary
Hypertrophy, Left Ventricular
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Dihydroxycholecalciferols
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents