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Vitamin D and Chronic Renal Insufficiency

Primary Purpose

Vitamin D Deficiency, Chronic Renal Insufficiency

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
Age > 18 years
Vitamin D insufficiency or deficiency (25-OHD < 50 nmol/l, 3 months before project start)

Exclusion Criteria:

Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
Hypercalcaemia (ca++ > 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
Uncontrolled hyperphosphataemia (s-phosphate > 2,2 mmol/l)
Sarcoidosis
Malignant disease
Psychotic disorders
Pregnancy and lactation women
Allergy to soya and peanut

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test

Secondary Outcome Measures

Health questionnaire

Full Information

NCT ID

NCT00968877

First Posted

August 28, 2009

Last Updated

January 25, 2011

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00968877

Brief Title

Vitamin D and Chronic Renal Insufficiency

Official Title

Vitamin D and Chronic Renal Insufficiency

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.

Detailed Description

Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D. However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment. We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Chronic Renal Insufficiency

Keywords

Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cholecalciferol

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Dekristol

Intervention Description

capsule 40 000 IU (p.o.) once per week, in 8 weeks.

Primary Outcome Measure Information:

Title

Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Health questionnaire

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic kidney disease (CKD 3-5 amd renal transplanted patients) Age > 18 years Vitamin D insufficiency or deficiency (25-OHD < 50 nmol/l, 3 months before project start) Exclusion Criteria: Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months) Hypercalcaemia (ca++ > 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D) Uncontrolled hyperphosphataemia (s-phosphate > 2,2 mmol/l) Sarcoidosis Malignant disease Psychotic disorders Pregnancy and lactation women Allergy to soya and peanut

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Marckmann, Prof, DMSc

Organizational Affiliation

Nephrological department, Odense University Hospital

Official's Role

Study Director

12. IPD Sharing Statement

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Vitamin D and Chronic Renal Insufficiency

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