Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
This study has been completed.
Sponsor:
Shiraz University of Medical Sciences
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
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
beta thalassemia
MedlinePlus related topics:
Thalassemia
Drug Information available for:
Hydroxyurea
Carnitine
Levocarnitine
Magnesium
Chlorine
Magnesium chloride
U.S. FDA Resources
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 |
|---|---|
|
Experimental: 1
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).
|
|
Active Comparator: 2
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).
|
|
Active Comparator: 4
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
|
|
Active Comparator: 3
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 | |
| 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
No publications provided
| Responsible Party: | Mehran Karimi, Shiraz University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00809042 History of Changes |
| Other Study ID Numbers: | SHaghpanah, 3342 |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 15, 2008 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Shiraz University of Medical Sciences:
|
Hydroxyurea magnesium chloride L-carnitine β-thalassemia intermedia |
Additional relevant MeSH terms:
|
Beta-Thalassemia Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Carnitine Hydroxyurea Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013