Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier:
NCT01395823
First received: July 14, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.


Condition Intervention Phase
End Stage Renal Disease
Dietary Supplement: ergocalciferol supplementation
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Dialysis Clinic, Inc.:

Primary Outcome Measures:
  • EPO dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.


Secondary Outcome Measures:
  • Active D dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The weekly active D sterol dose during the baseline period and 6 months will be compared.


Enrollment: 470
Study Start Date: June 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ergocalciferol supplementation Dietary Supplement: ergocalciferol supplementation
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
Other Name: vitamin D, D2
Placebo Comparator: placebo Other: placebo
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
Other Name: sugar pill

  Eligibility

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

Inclusion Criteria:

  1. Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
  2. Treated with EPO for at least 90 days. The mode of administration, intravenous (IV) or subcutaneous (SC), must remain the same for 90 days prior to enrollment.
  3. The method by which EPO is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the ceiling for the total EPO dose administered per week, if a ceiling is used, and the level of hemoglobin (Hgb) at which EPO is discontinued (Hgb cutoff), if a Hgb cutoff is used.
  4. The method by which IV Iron is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the serum ferritin and transferrin saturation (TSAT) targeted, if specific ferritin and TSAT targets are used

Exclusion Criteria:

  1. Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
  2. Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
  3. Active infection defined by the use of IV antibiotic use within the past 30 days.
  4. Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
  5. History of a hematological malignancy (e.g. multiple myeloma, leukemia).
  6. Sickle cell disease (sickle cell trait is not an exclusion).
  7. Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
  8. Transfusion for any reason within the past 30 days.
  9. Medical conditions that cause a reduction in the absorption of oral vitamin D including Crohn's disease, celiac sprue, cystic fibrosis and surgical removal of part or all of the stomach or intestine.
  10. Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
  11. Known allergy/adverse reaction to ergocalciferol.
  12. Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
  13. Average Kt/V < 1.3 on past three monthly labs. There must be at least 2 monthly Kt/V values in the past three months.
  14. Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
  15. Life expectancy less than 6 months.
  16. Kidney transplantation planned in the next 6 months.
  17. Switch to peritoneal dialysis planned in the next 6 months.
  18. Pregnant or planning to become pregnant within the next 6 months. A pre-menopausal woman must agree to use contraception for the duration of the study. If a woman has not had menses in over 12 months, consider this patient to be menopausal.
  19. Unable or unwilling to give informed consent.
  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: NCT01395823

Locations
United States, California
DCI - Redding
Redding, California, United States, 96003
United States, Georgia
DCI - Albany
Albany, Georgia, United States, 31701
United States, Louisiana
DCI - Shreveport
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
DCI - Boston
Boston, Massachusetts, United States, 02111
United States, Missouri
DCI- Columbia
Columbia, Missouri, United States, 65201
DCI - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
DCI- Omaha
Omaha, Nebraska, United States, 68131
United States, New Jersey
DCI - New Brunswick
New Brunswick, New Jersey, United States, 08903
DCI - North Brunswick
North Brunswick, New Jersey, United States, 08902
United States, Pennsylvania
DCI - Philadelphia
Philadelphia, Pennsylvania, United States, 19129
United States, Tennessee
DCI - Knoxville
Knoxville, Tennessee, United States, 37924
DCI - Maryville
Maryville, Tennessee, United States, 37804
Sponsors and Collaborators
Dialysis Clinic, Inc.
Investigators
Principal Investigator: Dana Miskulin, MD DCI
  More Information

No publications provided

Responsible Party: Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier: NCT01395823     History of Changes
Other Study ID Numbers: DCI-0002
Study First Received: July 14, 2011
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Ergocalciferols
Vitamin D
Epoetin alfa
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014