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CompletedNCT07863791Updated Oct 7, 2026

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

A Phase 2 interventional study of Omega 3 Fish Oil supplements and Deferasirox in Thalassemia Majors (Beta-Thalassemia Major), sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2026, registered Sep 2026).
Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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

02

Conditions studied

  • Thalassemia Majors (Beta-Thalassemia Major)

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Keywords

  • cardiac mri
03

In context

beta-Thalassemia

312 studies on the registry are indexed under beta-Thalassemia; 73 are open to participants now.

This study's enrollment of 100 is above the median of 38 across 215 interventional studies indexed under beta-Thalassemia.

Browse beta-Thalassemia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation

    beta thalassemia patients receiving the omega 3 supplementation and deferasirox

    Drug: Omega 3 Fish Oil supplements · Drug: Deferasirox

  • Active comparator
    beta thalassemia patients receiving standard of care and deferasirox

    50 patients beta thalassemia patients receiving standard of care and deferasirox

    Drug: Deferasirox

Interventions

  • beta thalassemia patients receiving standard of care receiving omega 3 supplemetaion and effect of this on liver and cardiac functions and transfuison index

  • beta thalassemia patients receiving standard of care and deferasirox and effect on liver and cardiac functions and transfusion index

06

What researchers measure

Primary outcomes

  1. Liver iron concentration

    measure the iron content of liver by MRI imaging with no need for biopsy in milliseconds

    Time frame: 6 months

Secondary outcomes

  1. transfusion index in ml/kg/year

    the total amount of packed red blood cells transfused per kilogram of body weight per year

    Time frame: 6 months

  2. hemoglobin in g/dl

    iron containing protein in red blood cells

    Time frame: 6 months

  3. serum ferritin in ng/ml

    the iron store in body which reflect iron overload

    Time frame: 6 months

  4. lactate dehydrogenase(LDH) in U/L

    marker of hemolysis increased in hemolysis

    Time frame: 6 months

  5. controlled attenuation parameter (CAP) in decibel per meter

    it is a measurement of attenuation of ultrasound waves by liver fat used to estimate the amount of hepatic steatosis

    Time frame: 6 months

  6. ejection fraction

    it is percentage of blood pumped out of ventricle during each heart beat compared with amount of blood present in ventricle before contraction

    Time frame: 6 months

  7. superoxide dismutase in units per mililiter(U/L)

    it is antioxidant enzyme that converts superoxide radicals imto hydrogen peroxide and oxygen protecting cells from oxidative damage

    Time frame: 6 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, Cairo Governorate 11511, Egypt
08

References and documents

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. PubMed 32956768 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07863791
Responsible party
Sponsor
First posted
Oct 7, 2026
Start date
Jan 1, 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026
Last update
Oct 7, 2026

Study contacts

neveen G andrawes, PHD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Fish Oils

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