Health Condition 1: E441- Mild protein-calorie malnutrition
Conditions
Interventions
Intervention1: Oral Nutritional Supplement ProhanceTM Junior: Take 200 ml of lukewarm milk. Add 3 levelled scoops (approx. 27g) of paediatric oral nutritional supplement. Stir continuously until disso
Sponsors
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically healthy children between 2-6 years of age and at risk of undernutrition defined as those between less than -1 and â??2 standard deviations of the WHO Child Growth Standards Median for weight for age. 2. Children who are picky eaters, defined as below, between 2-6 years of age and at risk of undernutrition. 3. Parents of children willing to give written informed consent Picky eating was defined as having at least two of the following: - eating only a limited number of foods; - being unwilling to try new foods; - refusing to eat vegetables and/or foods from other food groups; - showing strong food likes and dislikes; - displaying behaviour that disrupted mealtimes
Exclusion criteria
Exclusion criteria: 1. Children less than 2 years and greater than 6 years of age will be excluded. 2. Children with moderate or severe malnutrition 3. Lactose intolerant children 4. Gluten intolerant children 5. Hypersensitivity to any ingredient in product 6. History of preterm delivery 7. Birth weight less than 2500 or greater than 4000 g 8. Ongoing or Recurrent infections, diarrhoea, known case of acute and chronic hepatitis B or C, HIV or tuberculosis, or diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases, or diagnosis of congenital or genetic disorder or infantile anorexia nervosa. 9. Children under medications or agents that could modulate body weight including but not limited to diuretics, appetite stimulants, steroids, and growth hormones 10. Children with of history of consumption of any other nutritional supplement within last 3 months of enrolment in study. 11. Children who had an obese parent defined as measured or self-reported BMI greater than equal to 28 kg/m2; to minimise the impact of genetic and family environmental influences on childhood overweight development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean changes in growth as determined by weight-for-age Z scores from baseline to study end by plotting the measurements on WHO growth reference charts.Timepoint: Visit 1: Baseline Visit 2: One month ±7 days Visit 3: Three month ±7 days Visit 4: Six Month ±7 days Visit 5: Nine Month ±7 days Visit 6: End of intervention visit 12 Month ±7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in episodes of infection in the last one year to study end determined by assessing a. Number of times child was sick â?? self reported not requiring medical attention b. Number of times child was sick that required medical attention c. Number of days child was sick d. Requirement of hospitalization e. Number of days in hospital 2. Change in mental growth from baseline to study end. 3. Changes in growth as determined by height-for-age and height-for-weight Z scores from baseline to study end. 4. Mean changes in growth as determined by height-for-age and height-for-weight Z scores from baseline to study end. 5. Assessment of nutritional status and nutrient adequacy by a The total energy intake compared with the age specific recommendation will be calculated based on IFCT food charts. b Macronutrient intake compared with the age specific recommendation c Energy contribution of carbohydrates, fats and protein to the total energy intakeTimepoint: Visit 1: Baseline Visit 2: One month ±7 days Visit 3: Three month ±7 days Visit 4: Six Month ±7 days Visit 5: Nine Month ±7 days Visit 6: End of intervention visit 12 Month ±7 days | — |
Countries
India
Contacts
Public ContactDr Chintan Khandhedia
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Outcome results
None listed