Thalassemia Majors (Beta-Thalassemia Major)Phase 2NCT07863791
Effect of Omega 3 Fatty Acids on Heart and Liver in Beta Thalassemia Patients
A Phase 2 study testing Omega 3 Fish Oil supplements and Deferasirox in people with Thalassemia Majors (Beta-Thalassemia Major), run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Thalassemia Majors (Beta-Thalassemia Major)
- What is being tested?
- Omega 3 Fish Oil supplements and Deferasirox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Omega 3 Fish Oil supplements, Deferasirox
- Keywords
- cardiac mri
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 Fish Oil supplementsDrug
beta thalassemia patients receiving standard of care receiving omega 3 supplemetaion and effect of this on liver and cardiac functions and transfuison index
DeferasiroxDrug
beta thalassemia patients receiving standard of care and deferasirox and effect on liver and cardiac functions and transfusion index
| Study group | Role | What they receive |
|---|---|---|
| omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation | Experimental | beta thalassemia patients receiving the omega 3 supplementation and deferasirox Receives: Drug: Omega 3 Fish Oil supplements; Drug: Deferasirox |
| beta thalassemia patients receiving standard of care and deferasirox | Active comparator | 50 patients beta thalassemia patients receiving standard of care and deferasirox Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver iron concentration
measure the iron content of liver by MRI imaging with no need for biopsy in milliseconds
Measured: 6 months
Secondary outcomes (7)
transfusion index in ml/kg/year
the total amount of packed red blood cells transfused per kilogram of body weight per year
Measured: 6 months
hemoglobin in g/dl
iron containing protein in red blood cells
Measured: 6 months
serum ferritin in ng/ml
the iron store in body which reflect iron overload
Measured: 6 months
lactate dehydrogenase(LDH) in U/L
marker of hemolysis increased in hemolysis
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thalassemia Majors (Beta-Thalassemia Major)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be randomly assigned to two parallel groups. the intervention group will receive omega3 supplementation in addition to standard deferasirox therapy,while the control group will continue on standard deferasirox therapy alone. outcomes including cardiac and hepatic iron overload parameters will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- neveen G andrawes, PHD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863791
- Sponsor's protocol ID
- MS276/2026
- Other IDs
- MS 276/2026
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07863791
- Acronym / sponsor ID
- MS276/2026
- Keywords
- cardiac mri
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants will be randomly assigned to two parallel groups. the intervention group will receive omega3 supplementation in addition to standard deferasirox therapy,while the control group will continue on standard deferasirox therapy alone. outcomes including cardiac and hepatic iron overload parameters will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation | Experimental | Drug: Omega 3 Fish Oil supplements, Drug: Deferasiroxbeta thalassemia patients receiving the omega 3 supplementation and deferasirox |
| beta thalassemia patients receiving standard of care and deferasirox | Active comparator | Drug: Deferasirox50 patients beta thalassemia patients receiving standard of care and deferasirox |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 Fish Oil supplementsbeta thalassemia patients receiving standard of care receiving omega 3 supplemetaion and effect of this on liver and cardiac functions and transfuison index | Drug | omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation |
| Deferasiroxbeta thalassemia patients receiving standard of care and deferasirox and effect on liver and cardiac functions and transfusion index | Drug | beta thalassemia patients receiving standard of care and deferasirox, omega 3 group :beta thalassemia patients receiving standard of care +omega3 supplementation |
Primary outcome
Liver iron concentration
Time frame: 6 months
measure the iron content of liver by MRI imaging with no need for biopsy in milliseconds
7 secondary outcomes
transfusion index in ml/kg/year
Time frame: 6 months
hemoglobin in g/dl
Time frame: 6 months
serum ferritin in ng/ml
Time frame: 6 months
lactate dehydrogenase(LDH) in U/L
Time frame: 6 months
controlled attenuation parameter (CAP) in decibel per meter
Time frame: 6 months
ejection fraction
Time frame: 6 months
superoxide dismutase in units per mililiter(U/L)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 32956768European 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
neveen G andrawes, PHD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega 3 Fish Oil supplements and Deferasirox in people with Thalassemia Majors (Beta-Thalassemia Major), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver iron concentration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07863791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.