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Active Vitamin D Effect on Left Ventricular Hypertrophy

P

Per Ivarsen

Status and phase

Terminated
Phase 4

Conditions

Chronic Kidney Disease
Left Ventricular Hypertrophy
Secondary Hyperparathyroidism

Treatments

Drug: Alfacalcidiol

Study type

Interventional

Funder types

Other

Identifiers

NCT00175149
EX 0203 DK

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

1
Active Comparator group
Description:
Given alfacalcidiol. Dose adjusted after PTH level
Treatment:
Drug: Alfacalcidiol
2
No Intervention group
Description:
The untreated arm

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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