Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury
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
- To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA.
研究概览
简要总结
Iron overload is a life-threatening condition that can lead to liver disease, cardiac disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated free radicals. Both conditions of high and low iron stores may present with common signs and symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin, serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin.
The investigators are proposing a study to determine the effect of concurrent AA and iron supplementation on iron status of individuals with SCI. The investigators goal is to identify abnormal status that may be attributed to simultaneous supplementation of iron and AA to develop future supplementation protocols in this population for optimal iron status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years to 90 years of age
- •Medically stable
- •Chronic SCI (>6 months post injury) without regard to the level or completeness of lesion
- •Supplementation with:
- •A standard recommended dose of 120-200 mg oral elemental iron (tablet or liquid; ferrous sulfate, fumarate or gluconate forms) for a minimum of 6 months; or
- •A standard recommended dose of 250-2,000 mg AA per day for a minimum of 6 months; or
- •Both 120-200 mg oral elemental iron AND 250-2,000 mg AA per day for a minimum of 6 months.
排除标准
- •Acute cardiovascular, pulmonary or renal conditions
结局指标
主要结局
To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA.
时间窗: 1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation
次要结局
- Determine the prevalence of high iron status if receiving supplementation with both iron and AA compared to supplementation with iron or AA.(1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation.)