Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients

Study Overview
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Brief Summary
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Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin per os versus no treatment.

Official Title
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Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Drug: 25-OH-D vitamin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 years hematic PTH level twofold-ninefold the upper limit hematic level of 25-OH-D vitamin < 30 ng/ml Exclusion Criteria: renal transplant or peritoneal dialysis less than 3 years ago pregnancy breastfeeding

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25-OH-D vitamin<br> | Drug: 25-OH-D vitamin<br> <br> |
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital status | Death for all causes but traumatic. | During the follow up, every three months for three years | 
| Onset of non fatal myocardial infarction | Cumulative with the vital status | During the follow up, every three months for three years | 
| Onset of non fatal stroke | Cumulative with the vital status | During the follow up, every three months for three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatal myocardial infarction |  | During the follow up, every three months for three years | 
| non fatal myocardial infarction |  | During the follow up, every three months for three years | 
| fatal stroke |  | During the follow up, every three months for three years | 
| non fatal stroke |  | During the follow up, every three months for three years | 
| sudden death |  | During the follow up, every three months for three years | 
| death for other causes (not traumatic) |  | During the follow up, every three months for three years | 
| frequency of hypercalcemia (>10.5 mg/dl) |  | During the follow up, every three months for three years | 
| frequency of hyperphosphoremia (>5.5 mg/dl) |  | During the follow up, every three months for three years | 
| frequency of normal level of 25-OH-D vitamin (>30 ng/ml) |  | During the follow up, every three months for three years | 
| frequency of 25-OH-D vitamin >100 ng/ml |  | During the follow up, every three months for three years | 
| frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators |  | During the follow up, every three months for three years | 
| frequency of parathyroid surgery |  | During the follow up, every three months for three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic haemodialysis, 25-OH-D vitamin