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.: PACTR202401875833105 Date of Approval: 09/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of oral Liposomal Iron Supplementation on anemic and non anemic Iron-Deficiency Children age 6 up to 59 months
Official scientific title Interventional Effects of oral Liposomal Iron Supplementation in anemic and non anemic Iron-Deficiency Preschool Children: A Randomized, Double-Blind, Placebo-Controlled trial
Brief summary describing the background and objectives of the trial While observational evidence suggests a strong link between iron deficiency and anemia with developmental deficits, the evidence of a causal link through intervention studies is limited. To maximize the power of the interventional study to address the effect of liposomal iron supplementation, we will conduct this interventional study on apparently normal preschool children after neutralizing other factors such as socioeconomic standard, birth weight, and maternal education, and using the gold standard developmental screening tool; Age and Stage III (ASQ-3) before and after intervention, then evaluating changes in scores in comparison with the control and non-interventional groups. The primary objective of this intervention is to assess whether liposomal iron plus diet advice is superior to diet advice alone in terms of neurodevelopmental outcomes in children aged 6-59 months identified with non anemic iron defiecincy following screening. A secondary objective is assessing laboratory and anthropometric outcomes after intervention in children with anemic and nonanemic iron deficiency.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Mental and Behavioural Disorders,Nervous System Diseases,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date 01/03/2023
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 47
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group c by liposomal iron 1.4 mg per kg per day for 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. 47
Control Group placebo 1ml per kg per day 4months placebo) groups received the same regimen of placebo from a sachet of the same taste, color and amount identical in appearance to the iron supplementation with no active ingredients, packed in the same way as iron sachets prepared by trial pharmacist. 47 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age range 6 months till 59 months old at baseline screenin c–reactive protein (CRP) is negative at the start and also in follow-up analysis, Hb concentration is 7.0 g/dl or above, and heart rate within normal range no history of consumption of iron supplements for 4 months ago or history of blood transfusion, if anemia is found, no other causes rather than ID are present, the child has no chronic or acute diseases (except for asthma) over the time of follow-up. no hemolytic anemia established diagnosed hemoglobinopathy (e.g., sickle cell disease, beta thalassemia major), or neurological disability as cerebral palsy, developmental delay or fits. Children with a past history of prematurity, born small for date, or low birth weight below 2500 grams were excluded Infant: 13 Month(s)-24 Month(s),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 01/01/2023 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 assess whether liposomal iron plus diet advice is superior to diet advice alone in terms of neurodevelopmental outcomes in children aged 6-59 months identified with NAID following screening. baseline and after 4 months
Secondary Outcome to assess laboratory and anthropometric outcomes after intervention on anemic and NAID children. baseline and after 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia faculty of medicine yassen abdel ghaffar shebien el kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund shebien el kom menoufia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia faculty of medicine yassen abdel ghaffar shebien elkom Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator kerollos samaan kerosmn1@gmail.com 201091481841 yassen abdel gaffar
City Postal code Country Position/Affiliation
shebien el kom Egypt lecturer assistant
Role Name Email Phone Street address
Scientific Enquiries kerollos samaan kerosmn1@gmail.com 201091481841 shebien el kom
City Postal code Country Position/Affiliation
menoufia Egypt lecturer assistant
Role Name Email Phone Street address
Public Enquiries kerollos samaan kerosmn1@gmail.com 201091481841 yassen abdel ghaffar
City Postal code Country Position/Affiliation
menoufia Egypt lecturer assisstant
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 : kerosmn1@gmail.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