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

Sponsored by:	Shiraz University of Medical Sciences
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00809042

Purpose

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 .

Condition	Intervention	Phase
β-Thalassemia Intermedia	Drug: hydroxyurea Drug: L-carnitine and hydroxyurea Drug: hydroxyurea and magnesium chloride Drug: hydroxyurea,L-carnitine and magnesium chloride	Phase II

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Thalassemia

Drug Information available for: Hydroxyurea Magnesium Chlorides Carnitine Magnesium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Factorial Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:

Hematologic Parameters [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

echocardiographic parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hydroxyurea	Drug: hydroxyurea Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
2: Active Comparator L-carnitine and hydroxyurea	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).
4: Active Comparator L-carnitine , magnesium chloride and hydroxyurea	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
3: Active Comparator 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). 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

Ages Eligible for Study:	4 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809042

Locations

Iran, Islamic Republic of, Fars
Hematology Research Center of Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

Principal Investigator:

Mehran Karimi, Full Professor

Hematology Research Center of Shiraz University of Medical Sciences

More Information

Responsible Party:	Shiraz University of Medical Sciences ( Mehran Karimi )
Study ID Numbers:	SHaghpanah, 3342
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00809042
Health Authority:	Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:

Hydroxyurea
magnesium chloride
L-carnitine
β-thalassemia intermedia

Study placed in the following topic categories:

Hematologic Diseases
Hydroxyurea
Beta-thalassemia
Anemia
Anemia, Hemolytic
Thalassemia
Anemia, Hemolytic, Congenital

Thalassemia minor
Genetic Diseases, Inborn
Beta-Thalassemia
Hemoglobinopathies
Hemoglobinopathy
Carnitine

Additional relevant MeSH terms:

Vitamin B Complex
Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hematologic Agents

Enzyme Inhibitors
Pharmacologic Actions
Vitamins
Therapeutic Uses
Micronutrients
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009