Effect Of Indigenously Prepared Nutritional Supplement In Children With Mild To Moderate Acute Malnutrition In India Sub-Urban Region - A Prospective Facility-Based Study

Screening of kids of age between 2 to 6 visiting around 300 Anganwadi in sub-urban area in north Pune will be screened for acute malnutrition with help of NGO ‘Niramay’ and Anganwadi workers. Those falling under acute mild and moderate malnutrition, based on the consent given by the parents will be enrolled for trial group. Those not willing to consume trial supplement, but willing to enroll for health evaluation and guidance regarding home based dietary modification will be enrolled for control group for comparison.

 On screening visit, a written informed consent will be obtained from subject’s guardian/parents for their participation in the study. Subject’s demographic details will be taken. Subject will undergo clinical examination (general and systemic examination). Subject’s medical, surgical and treatment history will be taken. Subject’s current medication if any will be noted in the case record from (CRF).

 The subject will be considered for further evaluation as per the inclusion and exclusion criteria.

 Subject will be called for below visit schedule:

 Â·       Screening Visit (up to -7 days)

·       Baseline Visit (Day 1)

·       Visit 1 (Day 30 ± 5 days)

·       Visit 2 (Day 60 ± 5 days)

·       Visit 3 (Day 90 ± 5 days)

  Subject will undergo clinical examination (general and systemic examination). Subject’s anthropometric parameters along with Growth- Change in weight and height (WHO z-score) and Improvement-Change in mid arm circumference at screening and 90 days will be assessed.

 No. of days required to recover from episode of infection will be recorded. Subject’s change in appetite score, Child Eating Behaviour Questionnaire, emotional Quotient Questionnaire will be assessed. Global assessment of overall improvement will be done by subject’s parent and investigator on last follow up visit. Palatability with dosage compliance will be assessed by the investigator and by subject of test product from baseline to end of the study. All the subjects will be closely monitored for any adverse event/Serious Adverse Event starting from baseline visit till the end of the study visit. After completion of 90 days of study treatment, all the subjects will be asked to stop trial product/medications and take advice of investigator for further treatment.