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

Enterosorbent Intervention Therapies for Populations at risk of Aflatoxin-Related Diseases: Safety evaluation of Unifrom Particle NovaSil in Children (Phase I)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201311000711179

Enrollment

Registered

2013-11-22

Start date

2012-05-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning Paediatrics Aflatoxin exposure

Interventions

Unifrom Particle Size NovaSil (UPSN)

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Serum Biochemistry (CBC);Hematology	—

Secondary

Measure	Time frame
Urinary Aflatoxin M1 biomarkers	—

Countries

Ghana

Contacts

Public ContactNii-Ayi Ankrah

Associate Professor

Nankrah@noguchi.mimcom.org233(302)501178/9

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026