Clinical trial to evaluate the effect of vitamin D on renal progression in patients with Chronic Kidney Disease and vitamin D deficiency
- Conditions
- Chronic Kidney Disease in patients with D vitamin deficitTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2016-002913-23-ES
- Lead Sponsor
- Fundación Hospital Alcorcón
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 170
• Age 18-80 years
• Stage 3 Kidney Disease ( CKD EPI eGFR 60-30 ml / min / 1.73m2 )
• 25 OH vitamin D levels < 15 ng / Ml
• microalbuminuria / creatinine ratio > 30 mg / g confirmed in first morning urine
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
• Bone fracture in the last three months
• Previous condition of intestinal malabsorption or chronic diarrhea.
• Treatment with phenobarbital, phenytoin , rifampin , sucralfate , digoxin , steroids or other medication may affect the metabolism of vitamin D
• Previous liver failure
• Primary hyperparathyroidism
• calcimimetic treatment in the last 6 months
• active granulomatous disease
• Current treatment with some form of vitamin D
• Pregnancy- lactation
• Background of calcium nephrolithiasis well documented origin
• serum phosphate > 5.5 mg / dL in any determination in the last 3 months
• Serum calcium > 10.0 mg / dL in any determination in the last 3 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method