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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00809042
Date of registration: 15/12/2008
Primary sponsor: Shiraz University of Medical Sciences
Public title: Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
Scientific title: The Effect of Combination Therapy of Hydroxyurea With L- Carnitine and Magnesium Chloride on he-Matologic Parameters and Cardiac Function of ß-Thalassemia Intermedia Patients.
Date of first enrolment: June 2007
Target sample size: 120
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

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

Age minimum: 4 Years
Age maximum: 35 Years
Gender: Both
Health Condition(s) or Problem(s) studied
ß-Thalassemia Intermedia
Drug: hydroxyurea
Drug: hydroxyurea and magnesium chloride
Drug: hydroxyurea,L-carnitine and magnesium chloride
Drug: L-carnitine and hydroxyurea
Primary Outcome(s)
Hematologic Parameters [Time Frame: monthly]
Secondary Outcome(s)
echocardiographic parameters [Time Frame: 6 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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