Beta-ThalassemiaNCT06509581
Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen
A study testing vitamin E in people with Beta-Thalassemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury. oxidative stress play important role in pathogenesis of anemia in beta thalassemia. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Beta-Thalassemia
- What is being tested?
- vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2021to 11 Oct 2022
- Phase
- Interventional
- 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
- Beta thalassemia patients on regular packed red blood cells transfusion,with vitamin E deficiency
- serum ferritin 1000-2500 ug/l
- cardiacT2*>10ms and ejection fraction >55%
Who cannot join
- Diabetes,active hepatitis(serum transaminases >2 times ULN)
- renal impairment (serum creatinine>2times ULN)
- participation in previous investigational drug study with 3 months preceding screening supplementation with antioxidants or vitamins within 3 months prior to the study and patients with known allergy to vitamin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators
repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury.
oxidative stress play important role in pathogenesis of anemia in beta thalassemia.
vitamin E is often depleted in thalassemia patients.
Read the detailed description
oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients.
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes.
therefore, this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.
- Conditions
- Beta-Thalassemia
- Being tested
- vitamin E, PLACEBO
- Keywords
- thalasssemia, vitamin E, Oxidative stress
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin EDietary supplement
Vitamin E will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox )
PLACEBOOther
placebo will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox )
| Study group | Role | What they receive |
|---|---|---|
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E | Experimental | Beta thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving vitamin E in dose 400 mg daily for 12 months Receives: Dietary Supplement: vitamin E |
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo | Placebo comparator | B thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving placebo for 12 months Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of vitamin E on Liver iron concentration (LIC)
measuring the LIC using MRI (magnetic resonance imaging) in mg/g
Measured: 12 months
Secondary outcomes (2)
effect of vitamin E on antioxidants enzymes
measuring antioxidants enzymes
- antioxidant enzymes,
Measured: 12 months
effect of vit E supplementation on SF
measuring serum ferritin(SF)in ng/ml
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start5 Jul 2021
- Primary completion11 Sep 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Beta-ThalassemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abd el moneam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509581
- Sponsor's protocol ID
- MD12/2020
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fibach E, Rachmilewitz EA. The role of antioxidants and iron chelators in the treatment of oxidative stress in thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:10-6. doi: 10.1111/j.1749-6632.2010.05577.x.
PubMed 20712766ElLaboudy MA, Saber MM, Adly AA, Ismail EA, Ibrahim FA, Elalfy OM. Oxidative stress markers and tissue iron overload after 12-months vitamin E supplementation for children with transfusion-dependent beta-thalassemia on different iron chelators: A randomized placebo-controlled trial. Clin Nutr. 2025 Jul;50:154-163. doi: 10.1016/j.clnu.2025.05.003. Epub 2025 May 14.
PubMed 40424814
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators
- ClinicalTrials.gov ID
- NCT06509581
- Acronym / sponsor ID
- MD12/2020
- Conditions
- Beta-Thalassemia
- Keywords
- thalasssemia, vitamin E, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 19 Jul 2024 (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.
repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury.
oxidative stress play important role in pathogenesis of anemia in beta thalassemia.
vitamin E is often depleted in thalassemia patients.
Detailed description
oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients.
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes.
therefore, this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E | Experimental | Dietary Supplement: vitamin EBeta thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving vitamin E in dose 400 mg daily for 12 months |
| Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo | Placebo comparator | Other: PLACEBOB thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving placebo for 12 months |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Beta thalassemia patients on regular packed red blood cells transfusion,with vitamin E deficiency
- serum ferritin 1000-2500 ug/l
- cardiacT2*>10ms and ejection fraction >55%
Key exclusion criteria (3 listed)
- Diabetes,active hepatitis(serum transaminases >2 times ULN)
- renal impairment (serum creatinine>2times ULN)
- participation in previous investigational drug study with 3 months preceding screening supplementation with antioxidants or vitamins within 3 months prior to the study and patients with known allergy to vitamin
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 |
|---|---|---|
| vitamin EVitamin E will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox ) | Dietary supplement | Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E |
| PLACEBOplacebo will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox ) | Other | Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo |
Primary outcome
effect of vitamin E on Liver iron concentration (LIC)
Time frame: 12 months
measuring the LIC using MRI (magnetic resonance imaging) in mg/g
2 secondary outcomes
effect of vitamin E on antioxidants enzymes
Time frame: 12 months
effect of vit E supplementation on SF
Time frame: 12 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 19 Jul 2024.
- Background: PubMed 20712766Fibach E, Rachmilewitz EA. The role of antioxidants and iron chelators in the treatment of oxidative stress in thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:10-6. doi: 10.1111/j.1749-6632.2010.05577.x.
- Derived from this study: PubMed 40424814ElLaboudy MA, Saber MM, Adly AA, Ismail EA, Ibrahim FA, Elalfy OM. Oxidative stress markers and tissue iron overload after 12-months vitamin E supplementation for children with transfusion-dependent beta-thalassemia on different iron chelators: A randomized placebo-controlled trial. Clin Nutr. 2025 Jul;50:154-163. doi: 10.1016/j.clnu.2025.05.003. Epub 2025 May 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin E in people with Beta-Thalassemia, 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 3 inclusion and 3 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 19 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
effect of vitamin E on Liver iron concentration (LIC) (time frame: 12 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 NCT06509581, which also lists 2 linked publications.
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 19 Jul 2024.