Health Condition 1: E46- Unspecified protein-calorie malnutrition
Conditions
Interventions
Intervention1: Oral Nutritional supplement ONS 1: The ONS 1 is micronutrient fortified powder to be consumed as a nutritional supplement added to milk. There are no changes in the macronutrients compo
Sponsors
Hindustan Unilever Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Normal and mildly malnourished children with BMI-for-age percentiles [between 3rd to 25th percentile (-1.881) to (-0.674) z-score] by calculating as per WHO 5-19 years Growth Reference will be included 2.Screening for anemia will be done to include all children with hemoglobin =8 mg/dl 3.Children = 6 years to = 16 years will be included. (25-30 children per age). Stratification of pubertal (10 -15+ years) and prepubertal (6-9+ years) will be done later. Both boys and girls will be included 4.Children should not be lactose intolerant /have lactose sensitivity and be comfortable to have milk daily. [0 – (-1 SD) are normal children; (-1 to -1.9 SD) is defined as mild malnutrition; [-2 to -2.9 SD) is defined as moderate malnutrition; [(= -3) is defined as severe malnutrition]. [mild anaemia defined as 11 – 11.49 and 11 – 11.99 mg/dl for children 5-11 years and 12-14 years respectively; moderate anaemia defined as 8 - 10.99 mg/dl for children 5-11 years and 12-14 years respectively]
Exclusion criteria
Exclusion criteria: Children will be excluded at the time of screening, if they had been diagnosed or were known to: 1.be lactose intolerant and galactosaemic 2.be allergic or intolerant to wheat / any other cereal 3.have a current acute or chronic infection including but not restricted to respiratory infection, diarrhoea, Hepatitis B or C, HIV infection or tuberculosis. 4.have severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis; have a diagnosis of neoplastic, renal, hepatic or cardiovascular disease, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down’s syndrome, infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay. 5.diagnosed with disorders of haemoglobin structure, function, or synthesis according to medical records or parent/guardian report, or 6.have been diagnose with ADHD, any form of delayed / impaired cognitive development, delayed developmental milestones, or is on any form of medication for other cognitive conditions. 7.have had a clinically significant nutritional deficiency requiring specific treatment with another similar nutritional supplement (other than the study product) or 8.have any other clinically significant medical condition, which, in the investigator’s opinion, made the child unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of two high protein-micronutrient fortified drinks on physical growth of school children and adolescents as assessed by BMI-for-age percentilesTimepoint: 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of two high protein micronutrient fortified drinks on school children (6 – 16 years) as assessed by Anthropometric parameters 1) height-for-age 2) (weight, height, MUAC, waist circumference, Tricep skinfold) Body composition 3) Bio Impedance Analysis (BIA) 4) DEXA (in a sub sample) 5)bone mineral content (BMC DEXA 6) bone mineral density (BMD) by DEXA. 7) muscle mass by DEXA. 8) hand grip strength by hand dynamometer 9) cognitive function by CANTAB battery of testsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Somesh Bolegave
Siro Clintech Private Limited
Outcome results
None listed