Safety evaluation of Uniform Particle NovaSil in Children (Phase I study)

Not Applicable

• Conditions: Injury, Occupational Diseases, Poisoning; Paediatrics; Aflatoxin exposure

• Registration Number: PACTR201311000711179
• Lead Sponsor: oguchi Memorial Institute for Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1)Healthy (based on physical examinations)
2)No history of chronic illness
3)No use of prescribed medications for chronic or acute illness
4)Normal urinalysis (protein, glucose and bilirubin) using chemstrip
5)Normal hemoglobin level (greater than 10g/dl)
6)The parent or guardian must sign or thumb print the consent form.

Exclusion Criteria

1)Those not meeting the inclusion criteria
2)Abnormal hemoglobin level (below 10g/dl).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Biochemistry (CBC);Hematology

Secondary Outcome Measures

Name	Time	Method
rinary Aflatoxin M1 biomarkers