Chronic Renal Failure
Conditions
Keywords
chronic haemodialysis, 25-OH-D vitamin
Brief summary
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.
Interventions
DRUG25-OH-D vitamin
Sponsors
Società Italiana di Nefrologia
Italian Society of Nephrology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital status | During the follow up, every three months for three years | Death for all causes but traumatic. |
| Onset of non fatal myocardial infarction | During the follow up, every three months for three years | Cumulative with the vital status |
| Onset of non fatal stroke | During the follow up, every three months for three years | Cumulative with the vital status |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| fatal myocardial infarction | 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 |
| frequency of hyperphosphoremia (>5.5 mg/dl) | 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 |
Countries
Italy
Outcome results
None listed