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Active Vitamin D Effect on Left Ventricular Hypertrophy

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175149
Enrollment
24
Registered
2005-09-15
Start date
2002-01-31
Completion date
2008-12-31
Last updated
2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Left Ventricular Hypertrophy, Secondary Hyperparathyroidism

Keywords

CKD 3-4

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.

Interventions

DRUGAlfacalcidiol

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.

Sponsors

Per Ivarsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The effect of dihydroxycholecalciferol on left ventricular hypertrophy6 month

Secondary

MeasureTime frame
Changes in the activity of the renin-angiotensin system6 month
Changes in left ventricular function6 month

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026