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
Sponsored by
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
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
No
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
Learn more about this trial
Vitamin D and Chronic Renal Insufficiency
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