Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202797930675 Date of Approval: 15/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety evaluation of Uniform Particle NovaSil in Children (Phase II)
Official scientific title Safety and Efficacy of Calcium Montmorillonite Clay (Novasil) in Children at Risk of Aflatoxin related Diseases in Ejura Sekyedumase District, Ghana (PhaseII)
Brief summary describing the background and objectives of the trial Previous findings in Ghana's Ejura-Sekyedumase district suggest that children in this community are highly exposed to aflatoxins from maize and groundnuts, which are the main nutrient sources in weanimix, a nutritional food to prevent malnutrition. Aflatoxins are direct anti-nutrients that have been linked to stunted growth in infants and children in west Africa. Apart from their adverse effects on the liver and the immune system. The overall objectives of the study are as Calcium Montmorillonite Clay (Novasil) has proven to reduce aflatoxin bioavailability in children in a phase I study in Ghana. However, it is appropriate to broaden the scope of the phase I and to confirm whether novasil will be safe and efficacious when it is used for a longer period in children. Key objectives were to 1. Evaluate the impact of novasil intervention on the haematological and biochemical parameters 2. compare the levels of urinary aflatoxin M1 in participants before and after novasil treatment and monitor adverse effect.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/11/2020
Actual trial start date 20/06/2020
Anticipated date of last follow up 20/08/2020
Actual Last follow-up date 21/08/2020
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 198
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NOVASIL CLAY 1.5g of Novasil powder per day for 60 days 60 days Each participants received 1.5g of Novasil clay into their daily breakfast . 100
Control Group Calcium Carbonate 1.5 g /day for 60 days 60 days Calcium Carbonate (1.5g) was put into breakfast and consumed by participants for 60 days. 100 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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) Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 9 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/01/2020 Noguchi Memorial Institute for Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
South Legon Drive Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hematology, Serum Biochemistry and Urinary Aflatoxin M1 Biomarker Hematology Day 0- Bassline, Day 60 following treatment
Primary Outcome Biochemistry , Day 0- baseline, Day 60 following treatment
Secondary Outcome Urinary Aflatoxin M1 Day 0- baseline, Day 60 following treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ghana Ashanti Region EJURA 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
BASF BASF SE Food Fortification, G-ENH/MD Chemiestr. 22, 68623 Lampertheim, Germany Chemiestr. 68623 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor BASF BASF SE Food Fortification, G-ENH/MD Chemiestr. 22, 68623 Lampertheim, Germany Chemiestr. 68623 Germany Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Dr. Rein Dietrich Chemiestr 22 Lamperthein 68623 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justice Kumi jkumi@noguchi.ug.edu.gh +233244976215 Noguchi, South Legon drive
City Postal code Country Position/Affiliation
Accra 233 Ghana Research Officer
Role Name Email Phone Street address
Scientific Enquiries Desmond Omane Acheampong dacheampong@ucc.edu.gh 233543710234 University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Dietrich Rein dietrich.rein@basf.com +491743481295 Chemiestr. 22, 68623 Lampertheim
City Postal code Country Position/Affiliation
Chemiestr 68623 Germany Collaborator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data would be available to anyone who wishes to access the data especially researchers and policy makers. Informed Consent Form Data would be available immediately following publication. Data would be stored n external drive with hardcopies printed and stored under lock and key.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information