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

End Stage Renal Disease Clinical Trial

Official title:

Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395823
• Other study ID #: DCI-0002
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2011
• Last updated: February 15, 2016
• Start date: June 2011
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Dialysis Clinic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: June 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• ergocalciferol supplementation
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly

Other:
• placebo
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly

Locations

Country	Name	City	State
United States	DCI - Albany	Albany	Georgia
United States	DCI - Boston	Boston	Massachusetts
United States	DCI- Columbia	Columbia	Missouri
United States	DCI - Kansas City	Kansas City	Missouri
United States	DCI - Knoxville	Knoxville	Tennessee
United States	DCI - Maryville	Maryville	Tennessee
United States	DCI - New Brunswick	New Brunswick	New Jersey
United States	DCI - North Brunswick	North Brunswick	New Jersey
United States	DCI- Omaha	Omaha	Nebraska
United States	DCI - Philadelphia	Philadelphia	Pennsylvania
United States	DCI - Redding	Redding	California
United States	DCI - Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPO Dose	The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.	Baseline, 6 months	No