NCT00834301Unknown2 期
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Nephrian2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
研究概览
简要总结
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
- •Serum phosphorous level > 5 mg/dl
- •Stable phosphate binder regimen for 2 week prior to enrollment
- •Stable dose of Vitamin D for 4 weeks prior to enrollment
- •Stable calcimimetic dose for 4 week prior to enrollment
排除标准
- •patients who are pregnant
- •patients who have pre existing thrombocytopenia defined as a platelet count of <100 x 109/L
- •abnormal LFTs
- •baseline CRP > 15 g/dl
- •known sensitivity to any of the active ingredients
- •patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months
- •are currently taking any immunosuppressive medications
结局指标
主要结局
To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
时间窗: 8 weeks
次要结局
- To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population(8 weeks)
研究者
研究点 (2)
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