Health Condition 1: E46- Unspecified protein-calorie malnutrition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children in between 2 to 6 years of either sex.2.Guardian/ parent is willing to provide consent and follow the schedule of the study.3.Patient evaluated with Grade 1 and Grade 2 of Malnutrition (I.A.P Grading of Malnutrition)4.Patients with PEM
Exclusion criteria
Exclusion criteria: 1.Children who have Systemic diseases like Tuberculosis, Diabetes, any other grave infectious illness requiring active management. 2.PEM due to Gross congenital problems, Malignancies, Mal-absorption syndrome or inborn errors of metabolism will be excluded. 3.Children evaluated with other grades of PEM, i.e. normal, grade 3 4.and grade 4 as per IAP classification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Growth- Change in weight and height (WHO z-score) at screening and day 90.Timepoint: Screening Visit, Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in hematological parameters from screening to day 90. 2.Immunity profile - No. of recurrent acute upper respiratory tract infection (URTI), number of sick days per month assessed, number of days required to recover from episode of infection from screening to day 90. 3.Adverse events 4.Palatability with dosage compliance of test productTimepoint: Screening Visit, Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Countries
India
Contacts
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