Active Vitamin D Effect on Left Ventricular Hypertrophy

NCT00175149 | Terminated Phase 4

• 1 other identifier: EX 0203 DK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism; Left Ventricular Hypertrophy

Keywords

CKD 3-4

Outcome Measures

Primary Outcomes (1)

• The effect of dihydroxycholecalciferol on left ventricular hypertrophy

  6 month

Secondary Outcomes (2)

• Changes in the activity of the renin-angiotensin system

  6 month

• Changes in left ventricular function

  6 month

Study Arms (2)

1

ACTIVE COMPARATOR

Given alfacalcidiol. Dose adjusted after PTH level

Drug: Alfacalcidiol

2

NO INTERVENTION

The untreated arm

Interventions

Alfacalcidiol 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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Kidney transplantation
• Malignant disease

Sponsors & Collaborators

• Per Ivarsen: lead

Study Sites (1)

Department of Renal Medicne C, Skejby Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical

Study Officials

• Per Ivarsen, MD, PhD

  Deparment of Renam Medicine C, Skejby Hospital

  PRINCIPAL INVESTIGATOR

• Per Ivarsen, MD, PhD

  Deparment of Renal Medicine C, Skejby Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

DK (1)