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.: PACTR202303871481191 Date of Registration: 08/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of L carnitine supplementation on hemoglobin variability in maintenance hemodialysis patients
Official scientific title L carnitine and hemoglobin variability
Brief summary describing the background and objectives of the trial hemoglobin (Hb) variability is commonly observed in chronic hemodialysis patients. it is associated with mortality in some reports. L carnitine can be effective in treatment of erythropoietin (EPO) resistance in hemodialysis (HD) patients. in this study we assess the effect of L carnitine on Hb variability in HD patients
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 126
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 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
Experimental Group L carnitnine use 1 gram iv after HD session 6 months HD patients received l-carnitine iv after each HD sessions for 6 months 63
Control Group control group L carnitine not used 6 months HD patients received no l carnitine for 6 months 63 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age greater than 18 years receiving MHD three times per week infection, hemoglobin disorders, malignancy, gastrointestinal bleeding, blood transfusions defore study onset Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 29/11/2022 ain shams faculty of medicine
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hemoglobin variability difference assessed by residual standard deviation, mean absolute change, coefficient of hemoglobin variation 6 months after the start of the study
Secondary Outcome predictors of Hb variability 6 months after the start of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hospital 38 Abbassia, Next to the Al-Nour Mosque cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed sary gharib Almagd district, building 466 new obbour 11828 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed sary gharib Almagd district, building 466 Qalyubiyya 11828 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed sary gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
Role Name Email Phone Street address
Public Enquiries mohamed sary gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries mohamed sary gharib mohamedsary@med.asu.edu.eg +201000322177 Almagd district, building 466
City Postal code Country Position/Affiliation
new obbour 11828 Egypt ain shams university faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures) Statistical Analysis Plan,Study Protocol one year open request access
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