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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: β-Thalassemia Intermedia

Treatments: Drug: L-carnitine and hydroxyurea; Drug: hydroxyurea and magnesium chloride; Drug: hydroxyurea; Drug: hydroxyurea,L-carnitine and magnesium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00809042

3342

SHaghpanah

Details and patient eligibility

About

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 .

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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120 participants in 4 patient groups

1

Experimental group

Description:

Hydroxyurea

Treatment:

Drug: hydroxyurea

2

Active Comparator group

Description:

L-carnitine and hydroxyurea

Treatment:

Drug: L-carnitine and hydroxyurea

4

Active Comparator group

Description:

L-carnitine , magnesium chloride and hydroxyurea

Treatment:

Drug: hydroxyurea,L-carnitine and magnesium chloride

3

Active Comparator group

Description:

magnesium chloride and hydroxyurea

Treatment:

Drug: hydroxyurea and magnesium chloride