NCT00512824已完成不适用
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children Aged 1-6 Years in Low Socio-economic Urban Area of East Jakarta
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- The mean number of episodes and duration of acute diarrheal disease
研究概览
简要总结
This is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy children aged 1-6 years, with emphasize on aged 2-5 years, living permanently in low socio-economic urban areas of East Jakarta for at least 6 months
- •Parents are willing to sign the informed consent and give the supplements to the children for the period of 6 months
- •Capable and willing to drink liquid milk with a straw (acceptance to be tested at screening by providing a sample drink and placebo straw to be consumed under supervision for 2 days)
排除标准
- •Calcium intake exceeding 75% of the RDA for calcium (<375 mg/d) based on a Food Frequency Questionnaire
- •Currently breastfed children
- •Siblings of already included children that are living in the same household, except if it is a twin sibling
- •Severely malnourished with or without oedema (Weight for height-WHZ Z-score of <-3.00 SD)
- •Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and /or history of allergic disease.
- •Taking (any) antibiotics during 2 weeks prior to start of the study (children will be included after 3 weeks of last antibiotic intake
- •Participation in another clinical trial at the same time or 2 months prior to the start of this study
- •Both mothers and other caregivers present in the family are illiterate
结局指标
主要结局
The mean number of episodes and duration of acute diarrheal disease
时间窗: 24 weeks
次要结局
- Incidence of acute diarrheal disease(24 weeks)
- Severity of acute diarrheal disease(24 weeks)
- Intestinal and systemic inflammation(24 weeks)
- Intestinal colonization with pathogenic bacteria or viruses(24 weeks)
- Nutritional status based on anthropometric measurement(24 weeks)
- Iron and zinc status(24 weeks)
- Incidence, mean episodes and duration of acute respiratory infections(24 weeks)
研究者
研究点 (2)
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