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

Primary Purpose

β-Thalassemia Intermedia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hydroxyurea
L-carnitine and hydroxyurea
hydroxyurea and magnesium chloride
hydroxyurea,L-carnitine and magnesium chloride
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for β-Thalassemia Intermedia focused on measuring Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia

Eligibility Criteria

4 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Hematology Research Center of Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

4

3

Arm Description

Hydroxyurea

L-carnitine and hydroxyurea

L-carnitine , magnesium chloride and hydroxyurea

magnesium chloride and hydroxyurea

Outcomes

Primary Outcome Measures

Hematologic Parameters

Secondary Outcome Measures

echocardiographic parameters

Full Information

First Posted
December 15, 2008
Last Updated
December 15, 2008
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00809042
Brief Title
Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
β-Thalassemia Intermedia
Keywords
Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Hydroxyurea
Arm Title
2
Arm Type
Active Comparator
Arm Description
L-carnitine and hydroxyurea
Arm Title
4
Arm Type
Active Comparator
Arm Description
L-carnitine , magnesium chloride and hydroxyurea
Arm Title
3
Arm Type
Active Comparator
Arm Description
magnesium chloride and hydroxyurea
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
Intervention Description
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
Intervention Type
Drug
Intervention Name(s)
L-carnitine and hydroxyurea
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
hydroxyurea and magnesium chloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
hydroxyurea,L-carnitine and magnesium chloride
Intervention Description
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
Primary Outcome Measure Information:
Title
Hematologic Parameters
Time Frame
monthly
Secondary Outcome Measure Information:
Title
echocardiographic parameters
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehran Karimi, Full Professor
Organizational Affiliation
Hematology Research Center of Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Research Center of Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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