Clinical trial NCT00915317: Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency
Official title: Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Vitamin D Deficiency
Anemia
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hemodialysis patients at the Kaiser Permanente Los Angeles Medical Center with vitamin D deficiency \[defined by 25-hydroxyvitamin D level less than 30 ng/ml\].

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.


Eligibility criteria: 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

Primary outcomes:
measure: erythropoietin dosage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Phillip S Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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