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

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ClinicalTrials.gov Identifier: NCT00915317
Recruitment Status : Withdrawn (Before we could start the study, we realized that many of the patients were already getting ergocalciferol. Therefore, the study was closed.)
First Posted : June 8, 2009
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Vitamin D Deficiency Anemia

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 : October 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. erythropoietin dosage [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00915317     History of Changes
Other Study ID Numbers: 5125
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

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