NCT03170479已完成2 期
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Weight gain in children
研究概览
简要总结
i. To examine the impact of malnutrition on development quotient of children
ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age.
iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.
详细描述
- Research Instrument: For Development quotient Denver 2 screening form and tools will be used. Follow up of patients for three months and for recording of their weight Community management of acute malnutrition forms will be used. Denver screening tool will be used for child development quotient covering all areas of development, fine motor, gross motor, language and personal social contact.
- Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU).
- Study design: Randomized Controlled Trial.
- Data Collection: Lady Health Visitors (LHWs) will screen the children aged 6 months to 59 months in their community and will refer the severely malnourished children to Outpatient Therapeutic Programs (OTPs).Two groups of malnourished children will be made one study and one control group; one group will be treated with RUTF and extra virgin olive oil as placebo. Other will with RUTF and two mega doses of Vitamin D randomly, first after 15 days of enrollment and second after 15 days of first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Weight gain in children
时间窗: 2 Months
More than 15% weight gain from enrollment date
次要结局
- Developmental Milestones of children(2 Months)
研究者
Dr. Javeria Saleem
Principal Investigator
University of the Punjab
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