None listed
Conditions
Interventions
Intervention1: NRL/2019/5PNK: Protein supplement with micronutrient fortification
10 gm in 150 ml once in morning for 90 days
Control Intervention1: Marketed Product: Protein supplement with micronutr
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Children Aged 06 - 11 years inclusive (both gender) Consent: Understanding of the study and willingness to participate as evidenced by subjectâ??s parents and/or legal guardianâ??s voluntary written informed consent. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: Subject has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product Subject has a current illness requiring hospitalization Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study Subject is currently taking medication that could affect absorption/metabolism of study product or weight of the child. Exception: Topical/ocular steroids will be permitted during the study Subject is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma. (As per history and documentation in the medical records) Subject has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records) as per discretion of investigation Subject has a history of diabetes mellitus (as per history and documentation in the medical records) Subject has been on antibiotic therapy within the last one month before start of the study (before study Day 1) Subject has dysphagia, aspiration risk, and difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product. (As per history and documentation in the medical records) Subject has a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight (WHO z-score) Change in Anthropometric parameters Change in Blood biochemical tests - Serum iron, Serum calcium Questionnaire for evaluation of development and behaviour like- Motor activity, Cognition, memory skills, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing etc Change in Cardiopulmonary performance Timepoint: From baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Immunity profile Change in appetite score Emotional Quotient Questionnaire Changes in Liver Function test, Renal Function Test, Blood glucose, HbA1C, Thyroid Function Test, CBC etc. Change brain derived neuronal factor levels Adverse events Assessment of Overall Improvement by parent and investigator Palatability with dosage compliance Timepoint: From baseline to end of study | — |
Countries
India
Contacts
Public ContactMs Priya Khare
Netsurf Research Labs Pvt Ltd
Outcome results
None listed