The Safety and Efficacy of Oral Vitamin C Administration on Erythropoietin Dosing Requirement in End-Stage Renal Disease Patients on Regular Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
The study aimed to evaluate the safety and efficacy of oral vitamin C administration on erythropoietin dosing requirement in end-stage renal disease patients on regular hemodialysis.
详细描述
Erythropoietin deficiency is the most significant cause of anemia in chronic kidney disease (CKD) and has been demonstrated to occur at each stage of kidney failure. Because the kidney is the sole source of erythropoietin (EPO) synthesis in adults, reduction in kidney mass as occurs in progressive CKD often results in impairment of EPO production, resulting in anemia.
Vitamin C deficiency can interfere with iron absorption and utilization, as well as lead to various abnormalities. The occurrence of widespread vitamin C deficiency in dialysis patients calls for greater attention to these clinical problems. Ascorbic acid is low in patients with advanced CKD and end-stage renal disease (ESRD) due to dietary restrictions on vitamin C-rich foods, as these foods are usually also rich in potassium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >18 years.
- •Both sexes.
- •Stable hemodialysis (HD) for 90 days or more
- •Hemoglobin (HB) levels of 9-11 g/dL (as Hb levels above 11 g/dL, Epo dose reduction is recommended irrespective of iron level).
- •Erythropoietin (EPO) dose ≥4000 U/HD session and unchanged dose for two consecutive months
- •Ferritin level >100 mcg/L.
- •Transferrin saturation (Tsat) of <30 %.
- •Not on a vitamin C supplement.
- •Not receiving iron supplementation in the preceding 2 months. Each patient's previous 2-month stable dose of Epo was taken as the control.
排除标准
- •Patients with gastrointestinal bleeding.
- •Blood transfusion, malignancy.
- •Hospital admission or history of noncompliance with dialysis and/or medication were excluded from the study and were also censored if these events occurred during the study period.
研究组 & 干预措施
Group A
Patients were on normal regimen of treatment of anemia.
干预措施: Normal regimen of treatment of anemia (Drug)
Group B
Patients were on 250 mg oral vitamin C daily for 3 months.
干预措施: Vitamin C (Drug)
Group C
Patients were on 500 mg oral vitamin C daily for 3 months.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: 3 months post-procedure
Hemoglobin level was assessed every month for 3 months
次要结局
- Serum iron level(3 months post-procedure)
- Transferrin saturation(3 months post-procedure)
- Change in erythropoietin dose(3 months post-procedure)
研究者
marwa hassan
Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Ain Shams University