Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients (NUTRIVITA-D001)

Italian Society of Nephrology

Status and phase: Terminated; Phase 3

Conditions: Chronic Renal Failure

Treatments: Drug: 25-OH-D vitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT01457001

NUTRI-VITA-D001

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

25-OH-D vitamin

Experimental group

Treatment:

Drug: 25-OH-D vitamin

control

No Intervention group