NCT01263028终止不适用
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Ergocalciferol supplementation
Experimental
干预措施: Ergocalciferol supplementation (Drug)
结局指标
主要结局
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
时间窗: 24 Weeks
次要结局
- Change in Iron Supplementation(24 Weeks)
- Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels(24 Weeks)
- Change in Inflammatory Markers(24 Weeks)
- Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders(24 Weeks)
研究者
研究点 (1)
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