Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency
Sponsor
Kaiser Permanente (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00915317
Collaborator
(none)
0
1
5
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Outcome Measures
Primary Outcome Measures
- erythropoietin dosage [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Southern California | Los Angeles | California | United States | 90027 |
Sponsors and Collaborators
- Kaiser Permanente
Investigators
- Principal Investigator: Phillip S Yang, MD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
- Al-Aly Z, Qazi RA, González EA, Zeringue A, Martin KJ. Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD. Am J Kidney Dis. 2007 Jul;50(1):59-68.
- Coen G, Mantella D, Manni M, Balducci A, Nofroni I, Sardella D, Ballanti P, Bonucci E. 25-hydroxyvitamin D levels and bone histomorphometry in hemodialysis renal osteodystrophy. Kidney Int. 2005 Oct;68(4):1840-8.
- Del Valle E, Negri AL, Aguirre C, Fradinger E, Zanchetta JR. Prevalence of 25(OH) vitamin D insufficiency and deficiency in chronic kidney disease stage 5 patients on hemodialysis. Hemodial Int. 2007 Jul;11(3):315-21.
- DeVille J, Thorp ML, Tobin L, Gray E, Johnson ES, Smith DH. Effect of ergocalciferol supplementation on serum parathyroid hormone and serum 25-hydroxyvitamin D in chronic kidney disease. Nephrology (Carlton). 2006 Dec;11(6):555-9.
- Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Morinière P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25-(OH)vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol? Kidney Int. 1999 Jun;55(6):2169-77.
- González EA, Sachdeva A, Oliver DA, Martin KJ. Vitamin D insufficiency and deficiency in chronic kidney disease. A single center observational study. Am J Nephrol. 2004 Sep-Oct;24(5):503-10. Epub 2004 Sep 22.
- LaClair RE, Hellman RN, Karp SL, Kraus M, Ofner S, Li Q, Graves KL, Moe SM. Prevalence of calcidiol deficiency in CKD: a cross-sectional study across latitudes in the United States. Am J Kidney Dis. 2005 Jun;45(6):1026-33.
- Martins D, Wolf M, Pan D, Zadshir A, Tareen N, Thadhani R, Felsenfeld A, Levine B, Mehrotra R, Norris K. Prevalence of cardiovascular risk factors and the serum levels of 25-hydroxyvitamin D in the United States: data from the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2007 Jun 11;167(11):1159-65.
- Saab G, Young DO, Gincherman Y, Giles K, Norwood K, Coyne DW. Prevalence of vitamin D deficiency and the safety and effectiveness of monthly ergocalciferol in hemodialysis patients. Nephron Clin Pract. 2007;105(3):c132-8. Epub 2007 Jan 16.
- Shah N, Bernardini J, Piraino B. Prevalence and correction of 25(OH) vitamin D deficiency in peritoneal dialysis patients. Perit Dial Int. 2005 Jul-Aug;25(4):362-6.
- Taskapan H, Ersoy FF, Passadakis PS, Tam P, Memmos DE, Katopodis KP, Ozener C, Akcicek F, Camsari T, Ates K, Ataman R, Vlachojannis JG, Dombros NA, Utas C, Akpolat T, Bozfakioglu S, Wu G, Karayaylali I, Arinsoy T, Stathakis CP, Yavuz M, Tsakiris DJ, Dimitriades AD, Yilmaz ME, Gültekin M, Oreopoulos DG. Severe vitamin D deficiency in chronic renal failure patients on peritoneal dialysis. Clin Nephrol. 2006 Oct;66(4):247-55.
- Wolf M, Shah A, Gutierrez O, Ankers E, Monroy M, Tamez H, Steele D, Chang Y, Camargo CA Jr, Tonelli M, Thadhani R. Vitamin D levels and early mortality among incident hemodialysis patients. Kidney Int. 2007 Oct;72(8):1004-13. Epub 2007 Aug 8.
- Zadshir A, Tareen N, Pan D, Norris K, Martins D. The prevalence of hypovitaminosis D among US adults: data from the NHANES III. Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.
- Zisman AL, Hristova M, Ho LT, Sprague SM. Impact of ergocalciferol treatment of vitamin D deficiency on serum parathyroid hormone concentrations in chronic kidney disease. Am J Nephrol. 2007;27(1):36-43. Epub 2007 Jan 11.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00915317
Other Study ID Numbers:
- 5125
First Posted:
Jun 8, 2009
Last Update Posted:
Mar 11, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms: