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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00809042 |
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Date of registration:
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15/12/2008 |
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Primary sponsor: |
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Public title:
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Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
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Scientific 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 ß-Thalassemia Intermedia Patients. |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00809042 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Mehran Karimi, Full Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hematology Research Center of Shiraz University of Medical Sciences |
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Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
35 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ß-Thalassemia Intermedia
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Intervention(s)
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Drug: hydroxyurea
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Drug: hydroxyurea and magnesium chloride
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Drug: hydroxyurea,L-carnitine and magnesium chloride
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Drug: L-carnitine and hydroxyurea
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Primary Outcome(s)
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Hematologic Parameters
[Time Frame: monthly]
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Secondary Outcome(s)
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echocardiographic parameters
[Time Frame: 6 months]
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Secondary ID(s)
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3342
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SHaghpanah
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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