for Infection Prevention in Sickle Cell Anemia (ZIPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of infection
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 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.
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)
入排标准
- 年龄范围
- 1 Year 至 5 Years（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
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 the World Health Organization (WHO) (weight for length/height or height for age z-score <-3, using WHO growth standards)
结局指标
主要结局
Incidence of infection
时间窗: 12 months
The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.
次要结局
- Incidence of vaso-occlusive crisis (VOC)(12 months)
- Change in height-for-age z-score(Enrollment to 12 months)
- Incidence of zinc-related adverse events(12 months)
- Incidence of all clinical infections(12 months)
- Incidence of confirmed bacterial infections (by culture or PCR)(12 months)
研究者
Chandy John
Professor of Pediatrics
Indiana University