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

This study has been terminated.
(Before we could start the study, we realized that many of the patients were already getting ergocalciferol. Therefore, the study was closed.)
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00915317
First received: October 15, 2008
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

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
Vitamin D Deficiency
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • erythropoietin dosage [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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].

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915317

Locations
United States, California
Kaiser Permanente Southern California
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Phillip S Yang, MD Kaiser Permanente Southern California
  More Information

Publications:

Responsible Party: Philip Yang, MD, Kaiser Permanente Southern California
ClinicalTrials.gov Identifier: NCT00915317     History of Changes
Other Study ID Numbers: 5125
Study First Received: October 15, 2008
Last Updated: June 10, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Vitamin D Deficiency
Hematologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
 Epoetin Alfa
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013