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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00809042
Enrollment
120
Registered
2008-12-16
Start date
2007-06-30
Completion date
2007-12-31
Last updated
2008-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

β-Thalassemia Intermedia

Keywords

Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia

Brief 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 .

Interventions

DRUGhydroxyurea

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

DRUGL-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).

DRUGhydroxyurea 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.

DRUGhydroxyurea,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

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
4 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hematologic Parametersmonthly

Secondary

MeasureTime frame
echocardiographic parameters6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026