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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014