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.: PACTR201810893372771 Date of Approval: 11/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Zinc acceptability in children with acute Diarrhoea
Official scientific title Zinc acceptability in children with acute Diarrhoea
Brief summary describing the background and objectives of the trial Objective of this trial is to assess the palatability and acceptability of a new Zinc sulphate formulation for use in children with acute diarrhea Also to assess the compliance to the 10 day regimen of Zinc use in children with acute diarrhea.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) zincswipha
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Acute diarrhoea
Purpose of the trial Treatment: Other
Anticipated trial start date 19/11/2018
Actual trial start date 19/11/2018
Anticipated date of last follow up 28/12/2018
Actual Last follow-up date 28/12/2018
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group zincswipha Zinc sulphate tablet 10mg for children <6months; 20mg for children.6months daily 10days Zinc administration for management of acute diarrhea 360
Control Group zinc 10mg for children< 6months,20mg for those>6months dissolved in 5mls of breast milk or water 10 days the zinc tablets is given to all children that satisfy the inclusion criteria 360 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all children below 5 years presenting with acute diarrhea non severe severe dehydration co-morbidities like malaria hypersensitivity to Zinc Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 5 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
No 12/10/2018 Health research and Ethics Committee Lagos State University Teaching HospitalIkeja
Ethics Committee Address
Street address City Postal code Country
1-5 Oba akinjobi way, Ikeja Lagos Lagos 21105 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome adherence of children to the zinc sulfate regimen day 5 and 10
Secondary Outcome the taste acceptability of the zinc sulfate product day 10
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos state university teaching hospital ikeja 1-5 Oba akinjobi way, Ikeja Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Swiss pharma Nigeria Limited 5,Dopemu street,Agege Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swiss Pharma Nigeria Limited 5,Dopemu, Agege Lagos Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Omoniyi Yemitan 5 ,Oba akinjobi way Ikeja Lagos Nigeria
Dr. Idowu Senbanjo 1-5 Oba Akinjobi way Ikeja Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bamidele Mutiu bamidele.mutiu@lasucom.edu.ng +2348033565529 io block 14 Millenium estate Shasha
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Idowu Senbanjo senbanjo001@yahoo.com +2348067777363 1-5 Oba akinjobi way Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Omoniyi Yemitan kayodeyemitan@yahoo.com +23423056011 5 Oba akinjobi way Ikeja Lagos
City Postal code Country Position/Affiliation
lagos Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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