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.: PACTR201806003419426 Date of Approval: 27/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and tolerability of iron polymaltose and ferrous gluconate with lactoferrin as a combination in treatment of iron deficiency anemia
Official scientific title A comparative study of efficacy and tolerability of iron polymaltose and ferrous gluconate with lactoferrin as a combination in treatment of iron deficiency anemia
Brief summary describing the background and objectives of the trial Iron deficiency anemia (IDA) is the most common hematological disease of infancy and childhood resulting from deficiency of iron needed for synthesis of hemoglobin (Hb). It is characterized by a defect in Hb synthesis and drop in iron stores not supporting normal red blood cell production resulting in microcytic hypochromic anemia. Iron deficiency anemia screening by hemoglobin level is a simple screening method but the limitation of using Hb concentration as an individual measure of iron status is its lack of specificity and sensitivity, it is not the optimal way to identify children at risk from effects of iron deficiency as it fails to identify patients who are iron-deficient but are not anemic. However, following up Hb concentration is a good measure of response to treatment. The aim of work is to compare efficacy and compliance to iron formulations: Iron polymaltose alone and lactoferrin with ferrous gluconate as a combination in the treatment of iron deficiency anemia in children aged 2-6 years.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Iron deficiency anemia,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 31/08/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomi sation (variable block size) 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 iron polymaltose 6mg /kg/day Six weeks Oral drops (7mg elemental iron/ml) 50
Experimental Group ferrous gluconate and lactoferrin sachet twice daily Six weeks ferrous gluconate 67mg containing 8mg elemental iron and lactoferrin 100mg 30% saturation with iron containing 4.4mg elemental iron, vitamins (B,C) and minerals (zinc, iodine, folic acid and pantothenic acid) containing 12.4 mg elemental iron 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with iron deficiency (Microcytic hypochromic)anemia (Hb ¿9g/L) - Children with anemia due to other causes than iron deficiency anemia. - Previous blood transfusion. - Chronic illness (cardiac, renal or hepatic). - Patients with recent or recurrent infection. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 6 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 29/10/2017 IRB: Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champollion Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum iron before treatment and after 6 weeks
Primary Outcome Hemoglobin before treatment and after 2,4,and 6 weeks
Primary Outcome Serum ferritin before treatment and after 6 weeks
Secondary Outcome C-reactive protein (CRP) before treatment and after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Shatby Pediatric Hospital, Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric departement faculyty of medicine, Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric departement faculyty of medicine, Alexandria University Champollion St., Azarita Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tarek Mostafa Elwalily Portsaid street, El Shatby Alexandria 21526 Egypt
Rania El-Hadad Portsaid street, El Shatby Alexandria 21526 Egypt
Akram Abdel Moneim Deghady Champollion St., Azarita Alexandria 21521 Egypt
Mai mostafa elsayed mohamed soliman Portsaid street, El Shatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Elwalily tarekwalily@yahoo.com 002-01223479069 El shatby hospital, port said street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
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 Rania Elhadad canarycanary31@gmail.com 00201063305276 El shatby hospital, port said street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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