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Sponsored by: |
Shiraz University of Medical Sciences |
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Information provided by: | Shiraz University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00809042 |
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 .
Condition | Intervention | Phase |
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β-Thalassemia Intermedia |
Drug: hydroxyurea Drug: L-carnitine and hydroxyurea Drug: hydroxyurea and magnesium chloride Drug: hydroxyurea,L-carnitine and magnesium chloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Factorial Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Combination Therapy of Hydroxyurea With L- Carnitine and Magnesium Chloride on he-Matologic Parameters and Cardiac Function of β-Thalassemia Intermedia Patients. |
Estimated Enrollment: | 120 |
Study Start Date: | June 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hydroxyurea
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Drug: hydroxyurea
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
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2: Active Comparator
L-carnitine and hydroxyurea
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Drug: L-carnitine and hydroxyurea
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). L-carnitine (Minoo, Iran, 250 mg tablets) was administered in divided doses (50mg/kg/day).
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4: Active Comparator
L-carnitine , magnesium chloride and hydroxyurea
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Drug: hydroxyurea,L-carnitine and magnesium chloride
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). L-carnitine (Minoo, Iran, 250 mg tablets) was administered in divided doses (50mg/kg/day). Magnesium chloride powder ( tabib tajhiz nik, Iran) was formulated into suspension; each ml containing 1meq magnesium chloride. It was administered in divided doses at 0.6meq/kg/day
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3: Active Comparator
magnesium chloride and hydroxyurea
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Drug: hydroxyurea and magnesium chloride
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). Magnesium chloride powder ( tabib tajhiz nik, Iran) was formulated into suspension; each ml containing 1meq magnesium chloride. It was administered in divided doses at 0.6meq/kg/day.
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Ages Eligible for Study: | 4 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of, Fars | |
Hematology Research Center of Shiraz University of Medical Sciences | |
Shiraz, Fars, Iran, Islamic Republic of |
Principal Investigator: | Mehran Karimi, Full Professor | Hematology Research Center of Shiraz University of Medical Sciences |
Responsible Party: | Shiraz University of Medical Sciences ( Mehran Karimi ) |
Study ID Numbers: | SHaghpanah, 3342 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00809042 |
Health Authority: | Iran: Ethics Committee |
Hydroxyurea magnesium chloride L-carnitine β-thalassemia intermedia |
Hematologic Diseases Hydroxyurea Beta-thalassemia Anemia Anemia, Hemolytic Thalassemia Anemia, Hemolytic, Congenital |
Thalassemia minor Genetic Diseases, Inborn Beta-Thalassemia Hemoglobinopathies Hemoglobinopathy Carnitine |
Vitamin B Complex Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Hematologic Agents |
Enzyme Inhibitors Pharmacologic Actions Vitamins Therapeutic Uses Micronutrients Nucleic Acid Synthesis Inhibitors |