Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Study Overview
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Brief Summary
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Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.

Official Title
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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Conditions
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Chronic Kidney Disease Stages 3-5

Intervention / Treatment
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* Drug: Ergocalciferol supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease Age: >18yo Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose) Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month Serum 25-hydroxy Vitamin D levels < 30 ng/mL History of 25-hydroxy Vitamin D levels < 30 ng/mL currently on ergocalciferol replacement Exclusion Criteria: On hemodialysis Chronic kidney disease 5 Hypercalcemic (Calcium level > 11mg/dL) Pregnant female Iron deficient (iron saturation < 20%, Ferritin < 100ng/mL) Presence of active malignancy Presence of active infections Presence of active inflammatory properties Presence of blood dyscrasias Active bleeding or bleeding within the past 3 months (other than menses) B12 deficiency Folate deficiency Blood transfusion during participation Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ergocalciferol supplementation<br> | Drug: Ergocalciferol supplementation<br>* Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inflammatory Markers |  | 24 Weeks | 
| Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels |  | 24 Weeks | 
| Change in Iron Supplementation |  | 24 Weeks | 
| Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders |  | 24 Weeks |