Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ergocalciferol supplementation
placebo
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
- 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.
- 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.
- 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:
- Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
- Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
- Active infection defined by the use of IV antibiotic use within the past 30 days.
- Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
- History of a hematological malignancy (e.g. multiple myeloma, leukemia).
- Sickle cell disease (sickle cell trait is not an exclusion).
- Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
- Transfusion for any reason within the past 30 days.
- 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.
- Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
- Known allergy/adverse reaction to ergocalciferol.
- Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
- 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.
- Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
- Life expectancy less than 6 months.
- Kidney transplantation planned in the next 6 months.
- Switch to peritoneal dialysis planned in the next 6 months.
- 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.
- Unable or unwilling to give informed consent.
Sites / Locations
- DCI - Redding
- DCI - Albany
- DCI - Shreveport
- DCI - Boston
- DCI- Columbia
- DCI - Kansas City
- DCI- Omaha
- DCI - New Brunswick
- DCI - North Brunswick
- DCI - Philadelphia
- DCI - Knoxville
- DCI - Maryville
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
ergocalciferol supplementation
placebo
Arm Description
Outcomes
Primary Outcome Measures
EPO Dose
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01395823
Brief Title
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
Official Title
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dialysis Clinic, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ergocalciferol supplementation
Arm Type
Other
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
ergocalciferol supplementation
Other Intervention Name(s)
vitamin D, D2
Intervention Description
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
Primary Outcome Measure Information:
Title
EPO Dose
Description
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
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.
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.
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:
Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
Active infection defined by the use of IV antibiotic use within the past 30 days.
Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
History of a hematological malignancy (e.g. multiple myeloma, leukemia).
Sickle cell disease (sickle cell trait is not an exclusion).
Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
Transfusion for any reason within the past 30 days.
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.
Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
Known allergy/adverse reaction to ergocalciferol.
Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
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.
Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
Life expectancy less than 6 months.
Kidney transplantation planned in the next 6 months.
Switch to peritoneal dialysis planned in the next 6 months.
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.
Unable or unwilling to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Miskulin, MD
Organizational Affiliation
DCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
DCI - Redding
City
Redding
State/Province
California
ZIP/Postal Code
96003
Country
United States
Facility Name
DCI - Albany
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
DCI - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
DCI - Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
DCI- Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
DCI - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
DCI- Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
DCI - New Brunswick
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
DCI - North Brunswick
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States
Facility Name
DCI - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
DCI - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37924
Country
United States
Facility Name
DCI - Maryville
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
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