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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202410798909505 Date of Registration: 16/10/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Protective Effect of Alpha-Lipoic Acid Supplementation Against Oxidative Stress in Children and Adolescents with β- Thalassemia Major
Official scientific title Protective Effect of Alpha-Lipoic Acid Supplementation Against Oxidative Stress in Children and Adolescents with β- Thalassemia Major
Brief summary describing the background and objectives of the trial Oxidative stress plays a major role in the pathophysiology of β-thalassemia, which promotes the formation of reactive oxygen species (ROS), leading to oxidative stress, endothelial dysfunction, organ dysfunction, and tissue damage.ALA is a strong antioxidant that can inhibit reactive oxygen species, decreasing the oxidative stress and protecting against protein and lipid oxidation. the aim of the study is to evaluate the protective effect of alpha-lipoic acid (ALA) supplementation against oxidative stress in children and adolescents with β-thalassemia major by measuring serum level of asymmetric dimethylarginine (ADMA) and the phase angle (PhA) determined with bioelectrical impedance analysis (BIA) after 12 weeks of therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/07/2022
Actual trial start date 20/07/2022
Anticipated date of last follow up 01/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alpha lipoic acid 300 mg twice daily for three months children receive oral Alpha lipoic acid 300mg twice daily for 3 months then Blood samples obtained after at least 8 hours fasting, were taken at baseline for all participants and after the end of a three months to measure several biochemical measurements such as Serum ferritin, Lipid profile, ADMA and CRP. the phase angle (PhA) determined with bioelectrical impedance analysis (BIA) and anthropometric measurments (Weight (kg), height (cm), and body mass index (BMI) and their the corresponding z-scorevalues) were measured before and after the treatment. 30
Control Group placebo for three months children receive placebo twice daily for 3 months then Blood samples obtained after at least 8 hours fasting, were taken at baseline for all participants and after the end of a three months to measure several biochemical measurements such as Serum ferritin, Lipid profile, ADMA and CRP. the phase angle (PhA) determined with bioelectrical impedance analysis (BIA) and anthropometric measurments (Weight (kg), height (cm), and body mass index (BMI) and their the corresponding z-scorevalues) were measured before and after the treatment. 30 Placebo
Control Group Control group for three months healthy children of matched age and sex, chosen from the outpatient clinic to serve as a control group to compare our results with local people 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children and adolescents with β- thalassemia major aged 6 - 18 years of both sexes. Diagnosis of β-TM major was based on the history, clinical features, and hematological parameters of the patients 1. Children with other types of chronic hemolytic anemia. 2. Other diseases with vascular endothelium dysfunction as Hepatitis, diabetes mellitus, hypertension, infections, etc. 3. The presence of other diseases including hypo-/hyperthyroidism; cholestatic hepatitis, nephrotic syndrome, cardiac, and vascular disease. 4. Familial history of hypercholesterolemia, coronary artery disease, and premature atherosclerosis. 5. Patients with body mass index (BMI) ≥ 95th percentile. 6. History of serious health problems such as heart failure, hepatic and renal diseases, cancer, and gastrointestinal disorders interfering with alpha lipoic acid (ALA) absorption. 7. The use of corticosteroids. 8. Regular consumption of antioxidants or vitamin supplements. 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 23/05/2022 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum level of asymmetric dimethylarginine (ADMA) and phase angle (PhA) determined with bioelectrical impedance analysis (BIA) . after end of the treatment which is 3 months
Secondary Outcome C-reactive protein, Serum ferritin, Lipid profile: total cholesterol, high density lipoproteins cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) and triglycerides (TG),Anthropometric measures: Weight (kg), height (cm), and body mass index (BMI) and their corresponding z-score values and bioelectrical impedance analysis (BIA). after end of the treatment which is 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta University hospital Elgeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund el nahas 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
Nehal EL taib el geish street tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mai Emara mai3emara2022@gmail.com 01021008699 el nahas street
City Postal code Country Position/Affiliation
tanta Egypt assistant lecturer of pediatrics
Role Name Email Phone Street address
Public Enquiries Doaa El sawy doaaelsawy99@gmail.com 01023403551 Abo baker el sedek
City Postal code Country Position/Affiliation
tanta Egypt lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Doaa el sawy doaaelsawy99@gmail.com 01023403551 Abo baker el sedek
City Postal code Country Position/Affiliation
tanta Egypt lecturer of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share deidentifiedindividual trial participant data.All of the individual participantdata collected during the trialand after deidentification willbe available for anyone whowishes to acces Statistical Analysis Plan,Study Protocol after completion of researchand publication of the paper on request
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 04/10/2024 to add the aim of the study Oxidative stress plays a major role in the pathophysiology of β-thalassemia, which promotes the formation of reactive oxygen species (ROS), leading to oxidative stress, endothelial dysfunction, organ dysfunction, and tissue damage.ALA is a strong antioxidant that can inhibit reactive oxygen species, decreasing the oxidative stress and protecting against protein and lipid oxidation. so weevaluate the protective effect of alpha-lipoic acid (ALA) supplementation against oxidative stress in children and adolescents with β-thalassemia major by measuring serum level of asymmetric dimethylarginine (ADMA) and the phase angle (PhA) determined with bioelectrical impedance analysis (BIA) after 12 weeks of therapy. Oxidative stress plays a major role in the pathophysiology of β-thalassemia, which promotes the formation of reactive oxygen species (ROS), leading to oxidative stress, endothelial dysfunction, organ dysfunction, and tissue damage.ALA is a strong antioxidant that can inhibit reactive oxygen species, decreasing the oxidative stress and protecting against protein and lipid oxidation. the aim of the study is to evaluate the protective effect of alpha-lipoic acid (ALA) supplementation against oxidative stress in children and adolescents with β-thalassemia major by measuring serum level of asymmetric dimethylarginine (ADMA) and the phase angle (PhA) determined with bioelectrical impedance analysis (BIA) after 12 weeks of therapy.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/10/2024 to clarify the healthy control group Control Group, Control group, , for three months, healthy children of matched age and sex, chosen from the outpatient clinic to serve as a control group to compare our results with local people, 30, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/10/2024 forget to upload ethics letter TRUE, local ethical committee of faculty of medicine of tanta uinversity, elgeish street, Tanta, 31511, Egypt, , 23 May 2022, 0020403333666, ethical.committee@med.tanta.edu.eg, TRUE, local ethical committee of faculty of medicine of tanta uinversity, elgeish street, Tanta, 31511, Egypt, , 23 May 2022, 0020403333666, ethical.committee@med.tanta.edu.eg, 31903_30010_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/10/2024 upload ethics letter TRUE, local ethical committee of faculty of medicine of tanta uinversity, elgeish street, Tanta, 31511, Egypt, , 23 May 2022, 0020403333666, ethical.committee@med.tanta.edu.eg, 31903_30010_4737.pdf TRUE, local ethical committee of faculty of medicine of tanta uinversity, elgeish street, Tanta, 31511, Egypt, , 23 May 2022, 0020403333666, ethical.committee@med.tanta.edu.eg, 31903_30010_4737.pdf