Safety evaluation of Uniform Particle NovaSil in Children (Phase II)

Phase 2

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202202797930675

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1Healthy (upon physical examination by a physician)
2No chronic illness
3No use of medications for acute illnesses or chronic illness
4Aflatoxin M1 (AFM1) > 0.5ug/kg)
5Normal hemoglobin level (greater than 10.5g/dL)

Exclusion Criteria

1Abnormal hemoglobin level (below 10.5g/dl)
2Chronic illness
3Use of medications for chronic or acute illness.
4 Aflatoxin M1 (AFM1) <0.5ug/kg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematology, Serum Biochemistry and Urinary Aflatoxin M1 Biomarker ;Biochemistry

Secondary Outcome Measures

Name	Time	Method
rinary Aflatoxin M1