Active Vitamin D Effect on Left Ventricular Hypertrophy - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00175149

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 IV

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

The effect of dihydroxycholecalciferol on left ventricular hypertrophy [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in the activity of the renin-angiotensin system [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Changes in left ventricular function [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: No Intervention The untreated arm

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175149

Locations

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

Sponsors and Collaborators

University of Aarhus

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:	Dept of Renal Medicine C, Aarhus University Hospital, Skejby ( Per Ivarsen, MD,ph.d. )
Study ID Numbers:	EX 0203 DK
Study First Received:	September 11, 2005
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00175149
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

CKD 3-4

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Parathyroid Diseases
Renal Insufficiency
Heart Diseases
Ergocalciferols
Kidney Failure, Chronic
Endocrine System Diseases
Dihydroxycholecalciferols
Calcitriol
Calcium, Dietary

Hyperparathyroidism, Secondary
Hypertrophy
Vitamin D
Urologic Diseases
Hyperparathyroidism
Renal Insufficiency, Chronic
Neoplasm Metastasis
Endocrinopathy
Kidney Diseases
Cardiomegaly
Kidney Failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

Membrane Transport Modulators
Vitamins
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009