Clinical Trial of Manna Go Grain Supplement to promote growth, immunity and wellbeing in children.

Phase 2

• Registration Number: CTRI/2022/08/044931
• Lead Sponsor: Southern Health Foods Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Children Aged 06 - 12 years inclusive (both gender)

2. Healthy individual with no signs and symptoms of malnutrition

3. Subjectââ?¬•s parents understand and is willing, able and likely to comply with all study procedures and restrictions.

Exclusion Criteria

1. 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

2. Subject has a current illness requiring hospitalization

3. Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study

4. 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

5. 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)

6. 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

7. Subject has a history of diabetes mellitus (as per history and documentation in the medical records)

8. Subject has been on antibiotic therapy within the last one month before start of the study (before study Day 1)

9. 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)

10. 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
�Growth- Change in weight and height (WHO z-score at Day 1 and Day 90) <br/ ><br>�Changes in immunity markers like CD3, 4, 8 and IgG levels <br/ ><br>Timepoint: At Baseline and End of the study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
�Changes in PREFIT score for stamina <br/ ><br>�Hematological tests (CBC), Blood biochemical tests - Serum iron and Serum calcium <br/ ><br>�Immunity profile - No. of recurrent acute Upper Respiratory Tract Infection (URTI), number of sick days per month assessed, number of days required to recover from episode of infection <br/ ><br>�Change in appetite score <br/ ><br>�Changes in cognition questionnaire score <br/ ><br>�Assessment of Overall Improvement in growth, stamina and immunity, by parent <br/ ><br>Timepoint: At Baseline and End of the study