An open label clinical study to evaluate the efficacy and safety of Kids Nutri Immuno Supplement in improving the growth, cognition, performance, immunity and reducing the incidence of upper respiratory tract and gastrointestinal infections in children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same.
研究概览
简要总结
24 children with malnutrition and history of recurrent upper respiratory tract and gastrointestinal infections, will be enrolled in the study, For children aged 4–6 years, the dosage is 15g once daily for 8 weeks. For children aged 7–12 years, the dosage is 30g, which can be administered once or twice (two divided dosage) daily depending on the requirement for 8 weeks. Growth, cognition, performance, immunity and the incidence of upper respiratory tract and gastrointestinal infections will be assessed at each visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with malnutrition will be enrolled in the study. Performing a nutritional assessment that compares a childs measurements to standard values. Height for age.
- •Compared to the median of the WHO child growth standards, if the childs height is less than 2 standard deviations (SD) below, this is considered stunting. Weight for height- If the childs weight is less than 2 SD below the median of the WHO child growth standards, this is considered wasting and by measuring Mid Upper Arm Circumference (MUAC). Providing consent by understanding the study and willingness to participate as evidenced by subjects parents and or legal guardians voluntary written informed consent.
排除标准
- •Subject with a known allergy or intolerance to the study product or ingredients, on a special diet and cannot consume the study product.
- •Subject with a current illness requiring hospitalization, subject with GI infection and or acute diarrhea at the time of inclusion in the study.
- •Subject on medication that could affect absorption/metabolism of the study product.
- •If the subject is diagnosed with recurrent respiratory infections due to cystic fibrosis, active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history in the medical records) Subject with a history of diabetes (as per history and documentation in the medical records) Subject been on antibiotic therapy within the last 1 month before the start of the study (before study day 1) Subject with dysphasia, aspiration risk, and difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product (as per history and documentation in the medical records) Subject with a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator will also be excluded for the safety concern.
结局指标
主要结局
Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same.
时间窗: Day 0, Week 4 and week 8
Assessment of Emotional and Cognitive Intelligence Questionnaire based on the response from the subjects parent or guardian for cognition, social skills, motivation, self regulation, self awareness, and empathy. Academic performance will also be assessed between pre and post treatment.
时间窗: Day 0, Week 4 and week 8
Assessment of Child Eating Behaviour Questionnaire eating behaviour like food responsiveness, enjoyment of food, eating speed based on the response from the subjects parent or guardian
时间窗: Day 0, Week 4 and week 8
Montreal Cognitive Assessment will be assessed between pre and post treatment.
时间窗: Day 0, Week 4 and week 8
Incidence of URTI or GI health events during the study period
时间窗: Day 0, Week 4 and week 8
If infected during the study, with URTI or GI infections, the time taken for recovery will be monitored.
时间窗: Day 0, Week 4 and week 8
Number of school day losses
时间窗: Day 0, Week 4 and week 8
次要结局
- To monitor for any adverse events including lab abnormalities (CBC, RBS, RFT, LFT and Electrolytes) during the study period (baseline and post study lab parameters)(Baseline and week 8)
研究者
Dr Ananda Babu MBBS
Sree Lakshmi Hospital