Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency

Withdrawn

• Conditions: Anemia; Vitamin D Deficiency

• Registration Number: NCT00915317
• Lead Sponsor: Kaiser Permanente

Brief Summary

While vitamin D supplementation is safe and effective in repleting vitamin D levels in dialysis patients, the impact on anemia is unknown. The majority of hemodialysis patients require erythropoietin supplementation to maintain their serum hemoglobin between 11 and 12 gm/dL, a drug that is both costly and associated with significant side effects. If repletion of vitamin D significantly decreases erythropoietin requirements in hemodialysis patients, it would result in a substantial reduction in patient care costs. Our aim is to study the impact of ergocalciferol supplementation in hemodialysis patients with 25-hydroxyvitamin D deficiency. The investigators anticipate approximately 30% reduction in erythropoietin dose requirement in our hemodialysis population.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-15
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All hemodialysis patients at the Kaiser Permanente Los Angeles Medical Center with vitamin D deficiency [defined by 25-hydroxyvitamin D level less than 30 ng/ml]

Exclusion Criteria

• Non-renal causes of anemia (myelodysplastic syndrome, multiple myeloma, pure red cell aplasia, thallassemia, and sickle cell anemia)
• Active cancer
• AIDS
• refused erythropoeitin, intravenous iron or vitamin D analogs in the past
• no erythropoeitin requirement for greater than 6 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
erythropoietin dosage	6 months

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Los Angeles, California, United States