Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
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
- •All the selected children of Severe uncomplicated acute malnutrition of concerned age group whose parents or guardians have give written consent for the study
- •Mid Upper Arm Circumference (MUAC) less than 11.5 cm or Weight For Height (WFH) less then minus 3 standard deviation.
排除标准
- •Children above the concerned age group
- •Refusal of parents for taking part in the study.
- •Child having Severe Acute Malnutrition (SAM) with complications have loss of appetite, lower respiratory tract infection indicated by chest in drawing, severe vomiting.
- •Temperature greater then 39°C or hypothermia less then 35°C, very pale, oedema, unconsciousness.
研究组 & 干预措施
RUTF with Vitamin D
Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose.
干预措施: Ready to Use Therapeutic Food (RUTF) (Dietary Supplement)
RUTF with Placebo
Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.
干预措施: Ready to Use Therapeutic Food (RUTF) (Dietary Supplement)
RUTF with Vitamin D
Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose.
干预措施: Vitamin D (Dietary Supplement)
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