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.: PACTR202010465119274 Date of Approval: 30/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study For The Efficacy of Lactoferrin-100 versus Lactoferrin-100 and Ferrous Gluconate versus Ferric Hydroxide On Iron Deficiency Anemia
Official scientific title Comparative Study For The Efficacy of Lactoferrin-100 versus Lactoferrin-100 and Ferrous Gluconate versus Ferric Hydroxide On Iron Deficiency Anemia
Brief summary describing the background and objectives of the trial Iron deficiency anemia remains a major nutritional problem in developing countries, particularly in children. The prevalence of anemia in children and adolescents reaches to 39.6% in Egyptian preschool children. Lactoferrin (LF), discovered in 1939 in bovine milk and extracted in 1960 from both human and bovine milk. LF is one of the most important glycoproteins in iron homeostasis owing to its multifunctional activities. Lactoferrin is a member of the transferrin family of Iron binding glycoproteins. Human lactoferrin (HLF) is a glycoprotein formed of 691 amino acids, is constitutively expressed and secreted by glandular epithelial cells and by neutrophils following induction. The present study was conducted to estimate the effect of therapeutic doses of Lactoferrin 100, Lactoferrin 100, and ferrous gluconate compound and Ferric Hydroxide polymaltose on the outcome of iron deficiency anemia in the pediatric age group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2020
Actual trial start date 01/01/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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 randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lactoferrin and Ferrous Lactoferrin one packet 2 times daily + ferrous glauconate one packet 2 times daily for 3 months oral daily intake 50
Experimental Group Fe hydroxide polymaltose 6 mg/kg/day 3 times daily for 3 months daily oral intake 50
Control Group Lactoferrin one packet daily for 3 months daily oral intake 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Proved Iron deficiency anemia by decreased serum ferritin, decreased serum iron and decreased hemoglobin. Chronic anemias. Chronic diseases. Acute or chronic infections. Chronic blood loss. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 18 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 19/09/2019 Ethics Committee 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 Serum ferritin more than 20 mg/dl at 6 weeks and 12 weeks
Primary Outcome Serum iron for infants 40-100 mg/dl and for children 50-150 mg/dl at 6 weeks and 12 weeks
Secondary Outcome Hemoglobin level more than 11 gm dl at 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Children hospital Port saeed street, El-Shatby Alexandria 21321 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Youssef Port saeed street, El-Shatby Alexandria 21321 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Pediatrics Faculty of Medicine Alexandria University Port saeed street, El-Shatby Alexandria 21321 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Elkinany Port saeed street, El-Shatby Alexandria 21321 Egypt
Maha Youssef Port saeed street, El-Shatby Alexandria 21321 Egypt
Mostafa Rizk Port saeed street, El-Shatby Alexandria 21321 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Elkinany Hassanelkinany@yahoo.com 01002333438 Port saeed street, El-Shatby
City Postal code Country Position/Affiliation
Alexandria 21321 Egypt Professor of Pediatrics Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Maha Youssef kelklaly@hotmail.com 00201115944446 Port saeed street, El-Shatby
City Postal code Country Position/Affiliation
Alexandria 21321 Egypt Lecturer of Pediatrics Faculty of Medicine Alexandria University
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
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