Zinc for Infection Prevention in Sickle Cell Anemia-2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of all-cause infections in the zinc vs. placebo groups
研究概览
简要总结
A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)
详细描述
The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded placebo-controlled trial
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
- •Age range of 1.00-4.99 years, inclusive, at the time of enrollment
- •Weight at least 5.0 kg at the time of enrollment
- •Willingness to comply with all study-related treatments, evaluations, and follow-up
- •Children whose parents or guardians give full written informed consent
排除标准
- •Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
- •Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score <-3, using WHO growth standards)
- •Absolute neutropenia (absolute neutrophil count <500)
研究组 & 干预措施
Zinc
Dispersible zinc sulfate tablet (20 mg)
干预措施: zinc sulfate (Drug)
Placebo
Dispersible identical placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of all-cause infections in the zinc vs. placebo groups
时间窗: 6 months
Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm
次要结局
- Incidence of adverse events requiring discontinuation of study drug(6 months)
- Incidence of infections requiring hospitalization(6 months)
- Incidence of stroke or death(6 months)
研究者
Chandy John
Professor of Pediatrics
Indiana University