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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same.
Time Frame: 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.
Time Frame: 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
Time Frame: Day 0, Week 4 and week 8
Montreal Cognitive Assessment will be assessed between pre and post treatment.
Time Frame: Day 0, Week 4 and week 8
Incidence of URTI or GI health events during the study period
Time Frame: 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.
Time Frame: Day 0, Week 4 and week 8
Number of school day losses
Time Frame: Day 0, Week 4 and week 8
Secondary Outcomes
- 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)
Investigators
Dr Ananda Babu MBBS
Sree Lakshmi Hospital