Health Condition 1: E441- Mild protein-calorie malnutrition
Conditions
Interventions
Intervention1: Kids Nutri Immuno Supplement: 24 eligible participants will receive Kids Nutri Immuno Supplement daily orally for 8 weeks + standard of care treatment if required
Control Intervention1
Sponsors
Naturo Health Matters Pvt. Ltd.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same. 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. 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 Montreal Cognitive Assessment will be assessed between pre and post treatment. Incidence of URTI or GI health events during the study period If infected during the study, with URTI or GI infections, the time taken for recovery will be monitored. Number of school day losses Timepoint: Day 0, Week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)Timepoint: Baseline and week 8 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed