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.: PACTR202002763901803 Date of Approval: 24/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of lactoferrin and iron supplement for treatment of iron deficiency anemia in children with inflammatory bowel disease
Official scientific title Comparative study of lactoferrin and iron supplement for treatment of iron deficiency anemia in children with inflammatory bowel disease
Brief summary describing the background and objectives of the trial Inflammatory bowel disease (IBD) is one of the most common chronic diseases of childhood and its prevalence is increasing in both adult and pediatric populations. Anemia is the most common extraintestinal manifestation of IBD and can adversely affect quality of life. The pathophysiology of anemia in inflammatory bowel disease is multifactorial. The most obvious reason is gastrointestinal (GI) blood loss; however, sloughing of cells that line the GI tract, malabsorption and decrease in oral iron due to poor appetite can also contribute to iron deficiency anemia in IBD. In addition, the chronic inflammatory processes high hepcidin levels lead to inhibition of iron release from enterocytes decreased iron levels in the circulation and decrease its boiavailibility. Iron replacement include oral and intravenous (IV) iron supplementation are commonly used for treatment of anemia in inflammatory bowel disease, however oral iron supplementation frequently results in GI side effects, and theoretically, it may exacerbate IBD activity. Lactoferrin is a multifunctional protein and it has multiple biological roles as it is an antimicrobial protein and an immunostimulatory compound with anticancer agent and it also enhances iron absorption. Aim of the work: The aim of this study was to compare the effect of lactoferrin versus iron supplement in treatment of iron deficiency anemia in children with inflammatory bowel disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 Sealed opaque envelopes 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 iron supplement group elemental iron (6mg\kg\day) for 3 months Detailed medical history will be collected and blood samples will be obtained for routine investigation of iron deficiency anemia including CBC, hemoglobin level, serum ferritin, total iron binding capacity (TIBC) at baseline and after 3 months 40
Control Group lactoferrin group 100mg\day for 3months. Detailed medical history will be collected and blood samples will be obtained for routine investigation of iron deficiency anemia including CBC, hemoglobin level, serum ferritin, total iron binding capacity (TIBC) at baseline and after 3 months 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children of inflammatory bowel disease with iron deficiency anemia (Hb level less than 11 g\dl) will be included in our study patients with infection, other chronic diseases, personal or family history of allergy to cow's milk or recent iron supplement administration or blood transfusion within the previous 3 months will be excluded in our study Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 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 22/01/2020 Local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgiesh street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare the effect of lactoferrin versus iron supplement in treatment of iron deficiency anemia in children with inflammatory bowel disease before and at the end of the treatment
Secondary Outcome side effects of both drugs during and after 3 months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University hospital elgheish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dalia ElAfify Nile street Kafr Elsheikh Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia El Afifi daliaelafify@yahoo.com 00201006831039 Nile street
City Postal code Country Position/Affiliation
Kafr elsheikh Egypt lecturer of clinical pharmacy
Role Name Email Phone Street address
Public Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt consultant of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol and statistical analysis plan will be shared in a word document format Statistical Analysis Plan,Study Protocol within 24 months of beginning of the study controlled access after approval of the authors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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