Targeting the Interactions Between Disordered Iron Homeostasis and Mineral Metabolism in Chronic Kidney Disease (Aim 1)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in serum hepcidin levels
研究概览
简要总结
The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).
Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.
New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.
In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D < 30 ng/ml), and with absolute iron deficiency (TSAT < 20 and Ferritin <100) or iron restriction (TSAT < 20 and Ferritin > 100).
排除标准
- •Active vitamin D analog therapy or history of recent (< 3 months) use.
- •Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.
- •Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.
- •Oral iron therapy started within the last 3 months.
- •Hb < 8.0 g/dL for males and Hb <7.0 g/dL for females.
- •Pregnancy or lactation.
- •Serum calcium > 10.0 mg/dL or phosphorus > 4.5 mg/dL.
- •Subjects with acute kidney injury or rapidly declining GFR.
- •Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant.
- •Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.
研究组 & 干预措施
Oral Ergocalciferol
Oral Ergocalciferol 50000 IU once daily for 6 weeks
干预措施: Ergocalciferol 50000 UNT (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in serum hepcidin levels
时间窗: At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
Difference in change in serum hepcidin levels (ng/ml) over time between the two groups
次要结局
- Change in serum hemoglobin level(At Day 0, Day 3, 1 week, 4 weeks and 6 weeks)
- Change in serum iron level(At Day 0, Day 3, 1 week, 4 weeks and 6 weeks)
- Change in percent transferrin saturation(At Day 0, Day 3, 1 week, 4 weeks and 6 weeks)
- Change in serum ferritin level(At Day 0, Day 3, 1 week, 4 weeks and 6 weeks)
研究者
Bhupesh Panwar, MD
Principal Investigator
University of Alabama at Birmingham