Randomized control trial to assess the efficacy and safety of NRL/2019/5PNK withmicronutrient fortification to promote growth, health and wellbeing in children.

After Ethics committee’s approval, clinical study will beregistered on CTRI website. Children subjects of age between 06 to 11 years ofboth sex (inclusive) attending outpatient departments/consultation departmentof study site (s) will be screened for eligibility criteria. On screeningvisit, a written informed consent will be obtained from subject’sguardian/parents for their participation in the study. Subject’s demographicdetails will be taken. Subject will undergo clinical examination (general andsystemic examination). Subject’s medical, surgical and treatment history willbe taken. Subject’s current medication if any will be noted in the case recordfrom (CRF). The subject will be considered for further evaluation as per theinclusion and exclusion criteria. Subject will be called next day morning on emptystomach for laboratory testing. Subject’s blood sample will be collected at therespective study centers for laboratory testing i.e. CBC, ESR, Hb%, LiverFunction Tests, Renal Function test, HbA1c etc. Subject’s Urine Routine will bedone. During screening visit and the entire study duration subjects will beadvised to refrain from antioxidant agents, vitamins, health supplements,Nutraceuticals, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines. Ascreening window of 14 days will be kept, in case if there is delay inavailability of tests reports or in case few tests need to be repeated. Subjectwill be called for baseline visit assessment (day 0). On baseline visit,subject will be recruited in the study if he/she meets all the inclusion criteria.Subjects will then be randomized to one of the two study groups as per thecomputer generated randomization list. Subject’s parent/ guardian will be askedfor occurrence of any adverse event during screening period. Subject willundergo clinical examination (general and systemic examination). Subject’sgrowth- change in weight (WHO z-score), anthropometric parameters and bloodbiochemical tests - Serum iron, Serum calcium will be assessed. Thequestionnaire for evaluation of development and behavior like- Motor activity,Cognition, memory, social skills , Attention and concentration, Over activityand impulsivity, Perception of space and directions, Concepts of time,Perception of visual forms and figures, Passivity/inactivity andPlanning/organizing etc. and cardiopulmonary performance by VO2, will beassessed. At baseline visit and at every follow up visit (except last follow upvisit), as per computer generated randomization list, subjects will be providedwith containers each containing 350 gms (300 gms for 30 days + additional 50gms for use if follow up is delayed maximum up to 5 days) of either ‘KidsProtein Supplement’ or Standard. Subject will be advised to consume givensupplement in a dose of 10gms in the morning with 150 ml milk for 3 months.Subject will be advised to continue his concomitant medication other thanantioxidant agents, vitamins, health supplements, Nutraceuticals, Ayurvedic,Siddha, Unani, herbal /homeopathic medicines etc. The record of concomitantmedication will be kept in the CRF. Product compliance will be assessed by theinvestigator on every follow up visit. Subjects who continuously misses dosingfor >3 consecutive days or total missed dose > 9 days during the studyperiod will be treated as drop outs. Subjects will be allowed to come forfollow up either 5 days prior or after the scheduled follow up visit, providedsubject should continue the given treatment. Subjects will be called atrespective study sites for follow up visits after every month up to 3 monthsafter the baseline visit. On every follow up visit, Subject will undergoclinical examination. Subject’s growth- change in weight (WHO z-score),anthropometric parameters will be assessed. The questionnaire for evaluation ofdevelopment and behavior like- Motor activity, Cognition, memory, social skills, Attention and concentration, Over activity and impulsivity, Perception ofspace and directions, Concepts of time, Perception of visual forms and figures,Passivity/inactivity and Planning/organizing will be assessed. Subject’simmunity profile no. of recurrent acute Upper Respiratory tract infection(URTI), no. of sick days per month will be assessed by the presence of anyacute URTI, No. of days required to recover from episode of infection will berecorded. Subject’s change in appetite score, emotional Quotient Questionnairewill be assessed. On third follow up visit (i.e. Day 90) subject’s growth-change in weight (WHO z-score), anthropometric parameters and blood biochemicaltests - Serum iron, Serum calcium will be assessed. The questionnaire forevaluation of development and behavior like- Motor activity, Cognition, memory,social skills , Attention and concentration, Over activity and impulsivity,Perception of space and directions, Concepts of time, Perception of visualforms and figures, Passivity/inactivity and Planning/organizing etc. andcardiopulmonary performance by VO2, will be assessed. Subject’s immunityprofile no. of recurrent acute Upper Respiratory tract infection (URTI), no. ofsick days per month will be assessed by the presence of any acute URTI, No. ofdays required to recover from episode of infection will be recorded. Subject’schange in appetite score, emotional Quotient Questionnaire will be assessed.Global assessment of overall improvement will be done by subject’s parent andinvestigator on last follow up visit. Palatability with dosage compliance willbe assessed by the investigator and by subject of test product from baseline toend of the study. All the subjects will be closely monitored for any adverseevent starting from baseline visit till the end of the study visit. Aftercompletion of 3 months of study treatment, all the subjects will be asked tostop trial medications and take advice of investigator for further treatment.