NCT00809042

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 4 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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 .

Conditions

• β-Thalassemia Intermedia

Interventions

Type	Name	Description
DRUG	hydroxyurea	Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
DRUG	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).
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). 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.
DRUG	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

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2008-12-16
• Last updated: 2008-12-16

Locations

1 site across 1 country: Iran