Health Condition 1: null- Children with mild, moderate or severe malnutrition as per Gomezs Classification.
Conditions
Interventions
Intervention1: Amizate 3 grams: Amizate 3 grams with chocolate drinks, once a day, for 120days(4 months).
Intervention2: Amizate 6 grams: Amizate 6 grams with chocolate drinks, once a day, for 120days
Sponsors
Zymtech Production AS
Consortium Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female children, aged between 6 and 8 years. 2. Generally healthy (not having any serious diseases or indications or infections, which will be needing medical attention in a normal circumstance) on clinical examination as per the discretion of the physician on screening. 3. Ability and willingness of parent or legally acceptable representative to give written informed consent. 4. Ability and willingness of children to give assent. 5. Children with mild, moderate or severe malnutrition as per Gomez?s Classification. 6. The child must not be on any other nutritional supplement that is marketed, (if so, must be willing to withdraw consumption of the same immediately ? until this Seeding Program / User Trial is completed).
Exclusion criteria
Exclusion criteria: 1. History of cardiovascular or respiratory or any other diseases on clinical examination. 2. Physical disability, which limits performance of tests. 3. Indication that they are likely to move outside the Seeding Program / User Trial facility?s locality within the period Seeding Program / User Trial intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the weight, weight for age, height for age, weight for height, height Improvement in physical performance Improvement in cognitive performance Change in Minerals level, blood parameters, Lipid Profile, Liver Function Tests, Renal Function Tests, Assay for Immunological Parameters, urinalysis parameters Treatment-emergent serious adverse events Treatment discontinuation due to adverse events Timepoint: From Baseline till the End of Trial | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactMrs Nagalakshmi AnandaPadmanabhan
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Outcome results
None listed