Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Iron status
研究概览
简要总结
Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)], HIV-infected Ugandan children between the ages of 6 mos and 12 years.
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
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of HIV (based JCRC clinic records);
- •On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
- •Age 6 months - 12 years at the time of screening
- •Hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL (5 -12 years)by CBC at time of screening
排除标准
- •Acute illness or current opportunistic infection
- •Temperature >= 38.0°C at the time of screening
- •Known sickle cell disease
- •Acute malnutrition (bilateral pitting edema or extreme wasting)
- •Any chronic illness requiring regular medical attention
- •Residence > 50 km from JCRC hospital
- •Non-English or Luganda speaking
- •Currently taking iron supplements
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Ferrous Sulfate
Children 6 to 23 months of age will receive a tablet that contains the equivalent of 12.5 mg of elemental iron. Children over 24 months will receive a tablet that contains the equivalent of 30 mg of elemental iron.
干预措施: Ferrous Sulfate (Dietary Supplement)
结局指标
主要结局
Iron status
时间窗: 3 months
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Hemoglobin
时间窗: 3 months
Measurement of hemoglobin
Anemia
时间窗: 3 months
Prevalence of anemia
次要结局
- Dietary iron absorption(2 weeks)
- Sick Child Visits(3 months)
- HIV virologic control(3 month)
- HIV related immunosuppression(3 months)