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Active Vitamin D Effect on Left Ventricular Hypertrophy

NCT ID: NCT00175149

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Chronic Kidney Disease Secondary Hyperparathyroidism Left Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Given alfacalcidiol. Dose adjusted after PTH level

Group Type ACTIVE_COMPARATOR

Alfacalcidiol

Intervention Type DRUG

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

The untreated arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Per Ivarsen

OTHER

Sponsor Role lead

Responsible Party

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Per Ivarsen

Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per Ivarsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of Renam Medicine C, Skejby Hospital

Per Ivarsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Deparment of Renal Medicine C, Skejby Hospital

Locations

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Department of Renal Medicne C, Skejby Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EX 0203 DK

Identifier Type: -

Identifier Source: org_study_id