The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Age >18 years

• Ability to provide informed consent

• Chronic kidney disease stage 3 and 4

• On ACE inhibitor or ARB for albuminuria if tolerated

• Assessed during eligibility screen:

• Albuminuria >30 mg/g creatinine

• 25(OH) vitamin D level >12.5 and <75 nmol/L

Exclusion Criteria:

• On vitamin D in past 4 weeks

• Plans to relocate out of New York City in the next 6 months

• 25 (OH) Vitamin D level <12.5 nmol/L

• HIV infection

• History of hypercalcemia or kidney stones

• Serum phosphate >5.5 mg/dl in past 3 months

• Serum calcium >10.0 mg/dl in past 3 months

• SBP >160 DBP >100 at screening visit

• Transplanted organ

• Cancer

• Polycystic kidney disease

• Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months