Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00809042
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : December 16, 2008
Sponsor:
Information provided by:
Shiraz University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 16, 2008
Last Update Posted Date December 16, 2008
Study Start Date  ICMJE June 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
Hematologic Parameters [ Time Frame: monthly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
echocardiographic parameters [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
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 Arms  ICMJE
  • 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
 (submitted: December 15, 2008)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809042
Other Study ID Numbers  ICMJE SHaghpanah
3342
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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