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Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia

ConditionBeta Thalassemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTanta University

About this trial

The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with beta-thalassemia who will receive conventional thalassemia management.

Both genders.

Age ≥ 18 years old.

Disqualifiers

Patients with familial hypercholesterolemia or history of premature atherosclerosis.

Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.

Patients with severe renal dysfunction.

Patients with severe hepatic dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron chelating intervention

    Drug

    JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.

  • N Acetyl cysteine 600mg

    Drug

    N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.

  • Alpha Lipoic Acid 600 MG Oral Tablets

    Drug

    Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Group 1: (Iron chelating agent group)Active comparator 1 intervention
Group B: Group 2: (Iron chelating agent + NAC group)Active comparator 2 interventions
Group C: Group 3: (Iron chelating agent + ALA group)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

The change from baseline in carotid intima media thickness (CIMT)

Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness

Time frame
3 months

Secondary outcomes

1

Change in Malondialdehyde (MDA)

Malondialdehyde (MDA) level will be assessed using commercially available kit

Time frame
3 months
2

Change in high sensitivity C-reactive protein (hs-CRP)

High sensitivity C-reactive protein (hs-CRP) level will be assessed using commercially available kit.

Time frame
3 months
3

Change in asymmetric dimethyl arginine (ADMA)

Asymmetric dimethyl arginine (ADMA) level will be assessed using commercially available kit.

Time frame
3 months
4

Change in lipid profile

HDL, total cholesterol and triglycerides will be assessed using commercially available kits.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: