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

This study has been completed.

Sponsor:

Information provided by:

Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00809042

First received: December 15, 2008

Last updated: NA

Last verified: December 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 15, 2008

Last Updated Date

December 15, 2008

Start Date ^ICMJE

June 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 .

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

β-Thalassemia Intermedia

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Hydroxyurea

Intervention: Drug: hydroxyurea
Active Comparator: 2
L-carnitine and hydroxyurea

Intervention: Drug: L-carnitine and hydroxyurea
Active Comparator: 4
L-carnitine , magnesium chloride and hydroxyurea

Intervention: Drug: hydroxyurea,L-carnitine and magnesium chloride
Active Comparator: 3
magnesium chloride and hydroxyurea

Intervention: Drug: hydroxyurea and magnesium chloride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

December 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00809042

Other Study ID Numbers ^ICMJE

SHaghpanah, 3342

Has Data Monitoring Committee

Yes

Responsible Party

Mehran Karimi, Shiraz University of Medical Sciences

Study Sponsor ^ICMJE

Shiraz University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mehran Karimi, Full Professor

Hematology Research Center of Shiraz University of Medical Sciences

Information Provided By

Shiraz University of Medical Sciences

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top