Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
Phase 2
Completed
- Conditions
- β-Thalassemia Intermedia
- Interventions
- Drug: hydroxyurea,L-carnitine and magnesium chloride
- Registration Number
- NCT00809042
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
The purpose of this study is determination of the efficacy of combination of hydroxyurea with L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients with β-thalassemia intermedia in comparison with hydroxyurea alone .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Beta thalassemia intermedia patients with mean hemoglobin level >= 7gr/dl, need to blood transfusion with more than 6 months interval or no need to blood transfusion
Exclusion Criteria
- Hypothyroidism
- Hypoparathyroidism
- Diabetes mellitus
- Hepatitis B and C
- Positive tests for human immunodeficiency virus
- Any cardiac symptoms or receiving drug for cardiac disease
- Presence of other hemoglobinopathies except thalassemia intermedia and pregnant or lactating womens
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 3 hydroxyurea and magnesium chloride magnesium chloride and hydroxyurea 2 L-carnitine and hydroxyurea L-carnitine and hydroxyurea 4 hydroxyurea,L-carnitine and magnesium chloride L-carnitine , magnesium chloride and hydroxyurea 1 hydroxyurea Hydroxyurea
- Primary Outcome Measures
Name Time Method Hematologic Parameters monthly
- Secondary Outcome Measures
Name Time Method echocardiographic parameters 6 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the synergistic effects of hydroxyurea, L-carnitine, and magnesium chloride in β-thalassemia intermedia?
How does combination therapy with hydroxyurea and carnitine/magnesium compare to standard hydroxyurea monotherapy in β-thalassemia intermedia patients?
Which biomarkers correlate with improved hematologic parameters and cardiac function in β-thalassemia intermedia following hydroxyurea-carnitine-magnesium treatment?
What are the potential adverse events and management strategies for hydroxyurea-L-carnitine-magnesium chloride combination therapy in β-thalassemia intermedia?
Are there alternative combination therapies targeting erythropoiesis and mitochondrial function in β-thalassemia intermedia compared to NCT00809042's regimen?
Trial Locations
- Locations (1)
Hematology Research Center of Shiraz University of Medical Sciences
🇮🇷Shiraz, Fars, Iran, Islamic Republic of
Hematology Research Center of Shiraz University of Medical Sciences🇮🇷Shiraz, Fars, Iran, Islamic Republic of