Vitamin D and Chronic Renal Insufficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D and Chronic Renal Insufficiency

Conditions
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Vitamin D Deficiency, Chronic Renal Insufficiency

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol<br> | Drug: Cholecalciferol<br>* capsule 40 000 IU (p.o.) once per week, in 8 weeks.<br>* Other names: Dekristol;|
| Placebo Comparator: Placebo<br> | Drug: Cholecalciferol<br>* capsule 40 000 IU (p.o.) once per week, in 8 weeks.<br>* Other names: Dekristol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health questionnaire |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3