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

Safety and Efficacy of Calcium Montmorillonite Clay (Novasil) in Children at Risk of Aflatoxin related Diseases in Ejura Sekyedumase District, Ghana (PhaseII)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202202797930675

Enrollment

200

Registered

2022-02-15

Start date

2020-11-30

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Nutritional, Metabolic, Endocrine

Interventions

NOVASIL CLAY

Calcium Carbonate

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Hematology, Serum Biochemistry and Urinary Aflatoxin M1 Biomarker ;Biochemistry	—

Secondary

Measure	Time frame
Urinary Aflatoxin M1	—

Countries

Ghana

Contacts

Public ContactDietrich Rein

Collaborator

dietrich.rein@basf.com+491743481295

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026