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.: PACTR201911857573624 Date of Approval: 19/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lactoferrin versus iron polymaltose for the treatment of iron deficiency anemia in Egyptian children with cerebral palsy
Official scientific title Lactoferrin versus iron polymaltose for the treatment of iron deficiency anemia in Egyptian children with cerebral palsy
Brief summary describing the background and objectives of the trial A randomized controlled trial study will be conducted on (70) children out of 150 children with CP who were screened for IDA. The studied children aged from 1 year to 10 years with the diagnosis of CP, attending to Pediatric Neurology Outpatient Clinic of Alexandria University Children's Hospital (AUCH) with iron deficiency anemia. Children with CP will be randomly selected after fulfilling the inclusion criteria (35 children in each group), The primary outcome measures including analyses of biochemical indices of blood and anthropometric indices The aim of this work is s to improve the quality of care provided to children with cerebral palsy attending the Pediatric Neurology Outpatient Clinic of Alexandria University Children Hospital (AUCH) by assessment of the status of iron deficiency anemia among them and comparing between the efficacy of 30% iron saturated lactoferrin and iron polymaltose complex in the treatment of iron deficiency anemia in children with CP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Neonatal Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2019
Actual trial start date
Anticipated date of last follow up 30/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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 Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lactoferrin 100 mg/day twice daily One month a member of the transferrin family of iron-binding glycoproteins 35
Control Group Iron polymaltose 6 mg /kg /day elemental iron in 2 to 3 divided doses. One month combination of ferric iron with maltol (a food additive), 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with a formal diagnosis of cerebral palsy by a specialist in the management of children with cerebral palsy. children with cerebral palsy diagnosed with iron deficiency anemia. Children who have received oral iron preparations over the previous 6 months. Children having a medical or family history of beta thalassaemia or haemoglobinopathies. Children who are currently suffering from an acquired acute infectious illness. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 10 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 15/11/2018 Ethics Committee of Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemoglobin level After one month of treatment
Primary Outcome Serum ferritin After one month of treatment
Secondary Outcome Constipation After one month of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElShatby Pediatric hospital Alexandria university Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omneya Magdy Omar Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatrics Department Faculty of Medicine Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Mohamed Assem Shatby Hospital For Children Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
Omneya Magdy Omar Shatby Hospital For Children Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
Doaa Ibrahim Mohamed Shatby Hospital For Children Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Omneya Omar drmonymagdy@yahoo.com 0020122378859 Shatby Hospital For Children Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Assistant Professor of Pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Principal Investigator Hala Assem halamassem@yahoo.com 00201229383636 Shatby Hospital For Children Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics Faculty of Medicine University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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