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.: PACTR201311000711179 Date of Approval: 22/11/2013
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 I study)
Official scientific title Enterosorbent Intervention Therapies for Populations at risk of Aflatoxin-Related Diseases: Safety evaluation of Unifrom Particle NovaSil in Children (Phase I)
Brief summary describing the background and objectives of the trial Previous results from a survey in the Ejura-Sekyedumase district of Ghana, suggest that children in this community are highly exposed to aflatoxins from maize and peanuts that comprise the major nutrient source of weanimix, a nutritional food to prevent malnutrition. Besides their effects on the liver and immune system, aflatoxins are also direct anti-nutrients and have been correlated to growth faltering in infants and children in the West African Region.Overall goals of study are 1) to assess
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Aflatoxin exposure,Injury, Occupational Diseases, Poisoning,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/05/2012
Actual trial start date 12/06/2012
Anticipated date of last follow up 26/06/2012
Actual Last follow-up date 26/06/2012
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 63
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
not applicable
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation by simple count Determined by the holder of sequence situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Unifrom Particle Size NovaSil (UPSN) 0.75 g/day UPSN 14 days a low-dose UPSN 21
Experimental Group Unifrom Particle Size NovaSil (UPSN) 1.5 g/day UPSN 14 days a high-dose UPSN 21
Control Group Placebo 1.5 g/day calcium carbonate (placebo) 14 days Calcium carbonate 21 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 1)Those not meeting the inclusion criteria 2)Abnormal hemoglobin level (below 10g/dl). 3 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 17/02/2012 NOGUCHI MEMORIAL INSTITUTE FOR MEDICAL RESEARCH-IRB
Ethics Committee Address
Street address City Postal code Country
P. O. Box LG 581, Legon Accra Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum Biochemistry (CBC) Day 0 (baseline) Day 15 - following final treatment
Primary Outcome Hematology Day 0 - baseline Day 15 - following final treatment
Secondary Outcome Urinary Aflatoxin M1 biomarkers Day 0 (baseline) Day 7 (half-way point) Day 15 (following final treatment dose)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kotokoli line Ejura Ejura Sekydumase Di Ghana
Hiawoanwu N/A Ejura Ejura Sekydumase Dis Ghana
Dromankoma N/A Ejura Ejura Sekydumase Dis Ghana
Nkwanta N/A Ejura Ejura Sekydumase Dis Ghana
Kasei N/A Ejura Ejura Sekydumase Dis Ghana
Ejura fie N/A Ejura Ejura Sekydumase Dis Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development-Peanut Collaborative Research Program 1300 Pennsylvania Avenue NW Washington D.C. 20523 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Noguchi Memorial Institute for Medical Research P.O. Box 581, Univ Ghana, Legon Accra Gabon University
Secondary Sponsor Texas A&M University Intercollegiate Faculty of Toxicology College Station 77843-4458 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Nii-Ayi Ankrah P.O. Box LG 581, University of Ghana, Legon Accra Ghana
Timothy D. Phillips Intercollegiate Faculty of Toxicology Texas A&M University College Station 77843-4458 United States of America
Jia-Sheng Wang College of Public Health Athens, Georgia 30602 United States of America
Johnathan ¿Tim¿ Williams Peanut Collaborative Research Support Program, University of Georgia Griffin, Georgia 30223-1797 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nii-Ayi Ankrah Nankrah@mimcom.org 233(302)501178/9 PO Box LG 581, Univ Ghana, Legon
City Postal code Country Position/Affiliation
Accra Ghana Associate Professor
Role Name Email Phone Street address
Public Enquiries Nii-Ayi Ankrah Nankrah@noguchi.mimcom.org 233(302)501178/9 PO Box LG 581, Univ Ghana, Legon
City Postal code Country Position/Affiliation
Accra Ghana Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Timothy Phillips tphillips@cvm.tamu.edu 001(979)8624976 Intercollegiate Faculty of Toxicology, Texas A&M Univ
City Postal code Country Position/Affiliation
College Station, Texas 77843-4458 United States of America Professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information