A Phase 2 interventional study of hydroxyurea and L-carnitine and hydroxyurea in β-Thalassemia Intermedia, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 4 Years to 35 Years. Per ClinicalTrials.gov, last updated 2008-12-16.
Sponsored by Shiraz University of Medical Sciences · Phase 2, Interventional, and Treatment
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 .
416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.
This study's planned enrollment of 120 is above the median of 37 across 277 interventional studies indexed under Thalassemia.
Browse Thalassemia studies →Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hydroxyurea
Drug: hydroxyurea
L-carnitine and hydroxyurea
Drug: L-carnitine and hydroxyurea
L-carnitine , magnesium chloride and hydroxyurea
Drug: hydroxyurea,L-carnitine and magnesium chloride
magnesium chloride and hydroxyurea
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).
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 (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 (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
Hematologic Parameters
Time frame: monthly
echocardiographic parameters
Time frame: 6 months
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences