Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia

Study Overview
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Brief Summary
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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 .

Official Title
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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.

Conditions
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β-Thalassemia Intermedia

Intervention / Treatment
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* Drug: hydroxyurea
* Drug: L-carnitine and hydroxyurea
* Drug: hydroxyurea and magnesium chloride
* Drug: hydroxyurea,L-carnitine and magnesium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Hydroxyurea | Drug: hydroxyurea<br>* Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).<br>|
| Active Comparator: 2<br>L-carnitine and hydroxyurea | Drug: L-carnitine and hydroxyurea<br>* 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).<br>|
| Active Comparator: 4<br>L-carnitine , magnesium chloride and hydroxyurea | Drug: hydroxyurea,L-carnitine and magnesium chloride<br>* 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<br>|
| Active Comparator: 3<br>magnesium chloride and hydroxyurea | Drug: hydroxyurea and magnesium chloride<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic Parameters |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echocardiographic parameters |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia