Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
NCT ID: NCT00809042
Last Updated: 2008-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2007-06-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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1
Hydroxyurea
hydroxyurea
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
2
L-carnitine and hydroxyurea
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).
4
L-carnitine , magnesium chloride and hydroxyurea
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
3
magnesium chloride and hydroxyurea
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.
Interventions
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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 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).
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.
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
4 Years
35 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Shiraz University of Medical Sciences
Principal Investigators
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Mehran Karimi, Full Professor
Role: PRINCIPAL_INVESTIGATOR
Hematology Research Center of Shiraz University of Medical Sciences
Locations
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Hematology Research Center of Shiraz University of Medical Sciences
Shiraz, Fars, Iran
Countries
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References
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Foong WC, Loh CK, Ho JJ, Lau DS. Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.
Other Identifiers
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3342
Identifier Type: -
Identifier Source: secondary_id
SHaghpanah
Identifier Type: -
Identifier Source: org_study_id