Clinical trial of NRL/2019/5PNK to promote growth, health and wellbeing in children.

Phase 1

• Registration Number: CTRI/2019/11/021993
• Lead Sponsor: etsurf Communications Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in weight (WHO z-score) <br/ ><br>Change in Anthropometric parameters <br/ ><br>Change in Blood biochemical tests - Serum iron, Serum calcium <br/ ><br>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 <br/ ><br>Change in Cardiopulmonary performance <br/ ><br>Timepoint: From baseline to end of study

Secondary Outcome Measures

Name	Time	Method
Change in Immunity profile <br/ ><br>Change in appetite score <br/ ><br>Emotional Quotient Questionnaire <br/ ><br>Changes in Liver Function test, Renal Function Test, Blood glucose, HbA1C, Thyroid Function Test, CBC etc. <br/ ><br>Change brain derived neuronal factor levels <br/ ><br>Adverse events <br/ ><br>Assessment of Overall Improvement by parent and investigator <br/ ><br>Palatability with dosage compliance <br/ ><br>Timepoint: From baseline to end of study