Active Vitamin D Effect on Left Ventricular Hypertrophy | NCT00175149

Studies
Active Vitamin D Effect on Left Ventricular Hypertrophy

NCT00175149

Sponsor

Per Ivarsen

Status

Terminated

Last Update Posted

Dec 8, 2015Estimated

Enrollment

24Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease
Secondary Hyperparathyroidism
Left Ventricular Hypertrophy

Interventions

Alfacalcidiol

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of dihydroxycholecalciferol on left ventricular hypertrophy		6 month

Secondary Outcomes

Measure	Description	Time Frame
Changes in the activity of the renin-angiotensin system		6 month
Changes in left ventricular function		6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Renal Medicne C, Skejby Hospital		Aarhus		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D006962	Hyperparathyroidism, Secondary
D017379	Hypertrophy, Left Ventricular

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided