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.: PACTR202302847529384 Date of Registration: 06/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lactoferrin in obese children and adolescents with nonalcoholic fatty liver disease
Official scientific title Effect of lactoferrin in obese children and adolescents with nonalcoholic fatty liver disease
Brief summary describing the background and objectives of the trial Nonalcoholic fatty liver disease (NAFLD) is becoming one of the most highly prevalent liver diseases in overweight and obese children. In childhood, NAFLD can range from a simple fatty liver to a liver with inflammation and fibrosis (nonalcoholic steatohepatitis or NASH) to cirrhosis. The development of NAFLD been associated with insulin resistance (IR), hyperinsulinemia, dyslipidemia and increased systemic inflammation.Currently, there are no approved therapy and no firm conclusions regarding the efficacies of various treatment strategies for NAFLD. Lactoferrin is a glycoprotein that exerts immunomodulatory action and other multiple health benefits against infection, inflammation, and cancer. Several animal studies revealed that lactoferrin has regulatory effect on lipid metabolism and changes in hepatic steatosis and hepatic inflammation.The aim of this study is to determine the effect of lactoferrin in obese children and adolescents with nonalcoholic fatty liver disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2023
Actual trial start date 11/02/2023
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment group with lactoferrin 100 mg once daily 3 months Obese children and adolescents with NAFLD will receive lactoferrin 100 mg once daily for 3 months and laboratory tests will be carried out at baseline and after 3 months. 35
Control Group none No lactoferrin will be recieved 3 months Obese children and adolescents with NAFLD will not lactoferrin and laboratory tests will be carried out at baseline and after 3 months. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Obese children and adolescents with ultrasonography proven NAFLD Age 6-18 years other causes of liver disorders including viral hepatitis, autoimmune hepatitis, Wilson disease and hemochromatosis drug induced hepatotoxicity Adolescent: 13 Year(s)-17 Year(s),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 12/01/2023 Research ethics committee Faculty of Medicine Tanta Univerisity FWA00022834 IRB0010038
Ethics Committee Address
Street address City Postal code Country
Elgheish Street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurement of liver enzymes At baseline and afters 3 months
Secondary Outcome FBG, fasting insulin, total lipid profile, interleukin 6, interleukin 10, homocysteine At baseline and afters 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgheish Street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dalia El Afify Elgheish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Mediine Tanta Unversity Elgheish Street Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia El Afify daliaelafify@yahoo.com 00201006831093 Elgheish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assisstant Professor of Clinical Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Doaa El Amrousy doaamoha@yahoo.com 00201289022229 elmotasem street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Pediaterics
Role Name Email Phone Street address
Public Enquiries Wael El Feky waelfeky@yahoo.com 00201004332200 El nile street
City Postal code Country Position/Affiliation
Tanta Egypt Professor of Cardiothoracic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol and IPD data will be shared in a word document format as summary of results upon reasonable request Statistical Analysis Plan within 12 months of the end 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