Effect of Omega 3 Fatty Acids on Heart and Liver in Beta Thalassemia Patients

NCT07863791 — Phase 2, Completed, 100 participants, Ain Shams University

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Effect of Omega 3 Fatty Acids on Hepatic and Cardiac Iron Burden and Organic Function in Children and Adolescent With Transfusion Dependent Beta Thalassemia:A Randomized Controlled Trial

Registry	NCT07863791
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Thalassemia Majors (Beta-Thalassemia Major)
Interventions	Omega 3 Fish Oil supplements, Deferasirox (Drug)
Dates	start 2026-01-01, primary completion 2026-08-01, completion 2026-08-01, first posted 2026-10-07, last updated 2026-10-07
Locations	1 site in Egypt

-Summary

the aim of this interventional study to show the effect of taking omega 3 for about 6 months for patients beta thalassemia major maintained on standard of care and receiving the iron chelator deferasirox on liver, cardiac functions and transfusion index the patients randomly distributed to two groups group A receiving the omega 3 in dose 1gram pr day(50 patients) group b not receiving the drug

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+Arms and interventions

Arm	Type	Interventions	Description
omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation	Experimental	Drug: Omega 3 Fish Oil supplements; Drug: Deferasirox	beta thalassemia patients receiving the omega 3 supplementation and deferasirox
beta thalassemia patients receiving standard of care and deferasirox	Active comparator	Drug: Deferasirox	50 patients beta thalassemia patients receiving standard of care and deferasirox

Omega 3 Fish Oil supplements (Drug): beta thalassemia patients receiving standard of care receiving omega 3 supplemetaion and effect of this on liver and cardiac functions and transfuison index
Deferasirox (Drug): beta thalassemia patients receiving standard of care and deferasirox and effect on liver and cardiac functions and transfusion index

+Outcome measures

Primary outcomes

Liver iron concentration [6 months]: measure the iron content of liver by MRI imaging with no need for biopsy in milliseconds

Secondary outcomes

transfusion index in ml/kg/year [6 months]: the total amount of packed red blood cells transfused per kilogram of body weight per year
hemoglobin in g/dl [6 months]: iron containing protein in red blood cells
serum ferritin in ng/ml [6 months]: the iron store in body which reflect iron overload
lactate dehydrogenase(LDH) in U/L [6 months]: marker of hemolysis increased in hemolysis
controlled attenuation parameter (CAP) in decibel per meter [6 months]: it is a measurement of attenuation of ultrasound waves by liver fat used to estimate the amount of hepatic steatosis
ejection fraction [6 months]: it is percentage of blood pumped out of ventricle during each heart beat compared with amount of blood present in ventricle before contraction
superoxide dismutase in units per mililiter(U/L) [6 months]: it is antioxidant enzyme that converts superoxide radicals imto hydrogen peroxide and oxygen protecting cells from oxidative damage

+Eligibility

Sex: All, ages: 6 Years to 18 Years

Inclusion Criteria:

age: 6-18 years old children and adolescents with transfusion dependent thalassemia(TDT).diagnosis of TDT is based on clinical severity and transfsion requirements according to thalassemia international federation(TIF)guidelines

Exclusion Criteria:

* patients with infection or other inflammatory conditions patient with active hepatitis(serum transaminases>3 times above upper limit of normal) participation in previous clinical trial or supplementation with antioxidants or vitamins with three months prior to study

+Locations (1)

Facility	City	Country	Status
Ain Shams University	Cairo, Cairo Governorate	Egypt

+Publications

European Association for the Study of the Liver; Clinical Practice Guidelines Panel: Chair:; EASL Governing Board representative:; Panel members:. EASL recommendations on treatment of hepatitis C: Final update of the series☆. J Hepatol. 2020 Nov;73(5):1170-1218. doi: 10.1016/j.jhep.2020.08.018. Epub 2020 Sep 15. PMID 32956768

+Investigators

neveen G andrawes, PHD, Principal investigator, Ain Shams University