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.: PACTR202404915122192 Date of Approval: 05/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative study to evaluate the efficacy and tolerability of new generations of iron preparations with traditional iron therapy in pediatrics: A prospective randomized controlled trial.
Official scientific title A comparative study to evaluate the efficacy and tolerability of new generations of iron preparations with traditional iron therapy in pediatrics: A prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Iron deficiency (ID) and iron deficiency anemia (IDA) are highly prevalent worldwide. Oral iron salts, especially ferrous sulfate, are commonly used for the treatment of iron deficiency (ID). However, its use is associated with gastrointestinal side effects, thus compromising treatment compliance. Limitations associated with conventional iron salt led to emergence of different oral iron preparations like iron bisglycinate chelate, liposomal iron, sucrosomial iron , Micro dispersed iron, and Micronized sun active iron and ferrous bisglycinate. So, we aimed to compare the efficacy and tolerability of oral iron polymaltose complex, Micro dispersed iron, sun active iron, liposomal iron, sucrosomial iron, and iron bisglycinate chelate in treatment of IDA and to compare their effect on growth in preschool children aged 6-59 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/06/2022
Actual trial start date 06/06/2022
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date 01/01/2024
Anticipated target sample size (number of participants) 87
Actual target sample size (number of participants) 720
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group 1 by Iron polymaltose complex 6 mg / kg/day 4 months Iron polymaltose complex syrup 50 mg/ 5 ml, dose calculated according to weight 6 mg / kg/day and given once daily 120 Active-Treatment of Control Group
Experimental Group group 2 by Liposomal iron 1.4 mg/kg/ day 4 months one dose of liposomal iron therapy per day, six days per week. Each Sachet contains 19 mg equivalent liposomal iron pyrophosphate, which reconstructed into 19 ml water forming suspension of 1mg \ 1ml. Each participant received dose which was calculated according to monthly updated weight as 1.4 mg \kg \day. 120
Experimental Group group 3 by Iron Bisglycinate Chelate 0.45 mg /kg/day 4 months sachets each sachet (10 mg) dissolved in 10 ml water forming suspension of 1mg \ 1ml. , dose calculated according to weight 0.45 mg /kg/day 120
Experimental Group group 4 by Micro dispersed iron 7.5mg twice a day to children below 4 years old and 15mg twice a day to children above 4 years old 4 months in the form of a 350gm jar of liquid chocolate. At the dose of 7.5mg twice a day to children below 4 years old and 15mg twice a day to children above 4 years old 120
Experimental Group group 5 by sun active iron 14 mg/day 4 months Syrup and given 10 ml /day equivalent to 14 mg sun active iron 120
Experimental Group group 6 by sucrosomial iron 10 mg/ day 4 months sackets reconstructed into 10 ml water and given once daily. 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age range 6 months till 59 months old no evidence of infection and negative c–reactive protein (CRP) hemoglobin below the WHO stipulated cutoff values to define IDA anemia: hemoglobin <11.0 g/dL, MCV <73 fL and serum ferritin < 12 mg/L. no history of consumption of iron supplements for 4 months ago or history of blood transfusion. Children who had any signs of infection (fever, vomiting or diarrhea) on blood collection days, children with anemia rather than IDA e.g. hemolytic anemia or haemoglobinopathy (sickle cell disease, beta thalassemia major) children with chronic diseases or drugs that may affect iron absorption Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 19/02/2024 Institutional Research Board of Menoufia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
yassen abdel ghaffar shebien el kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the efficacy and tolerability of oral iron polymaltose complex, Micro dispersed iron, sun active iron, liposomal iron, sucrosomial iron, and iron bisglycinate chelate in treatment of IDA in preschool children aged 6-59 months. baseline and after 4 months
Secondary Outcome to compare their effect on growth. baseline and after 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia faculty of medicine Yassen abdel ghaffar shebein el kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund yassen abdel ghaffar shebien el kom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia faculty of medicine yassen abdel ghaffar shebien el kom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba El Zefzaf heba_magdy4@yahoo.com 00201003717845 yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebien el kom 32511 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Heba El Zefzaf heba_magdy4@yahoo.com 00201003717845 yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebien el kom 32511 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Heba El Zefzaf heba_magdy4@yahoo.com 00201003717845 yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebien el kom 32511 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal after approval by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Proposals should be directed to email :heba_magdy4@yahoo.com 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