β-Thalassemia IntermediaPhase 2NCT00809042
Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia
A Phase 2 study testing hydroxyurea, L-carnitine and hydroxyurea and hydroxyurea and magnesium chloride in people with β-Thalassemia Intermedia, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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 . Read more about this study
- Who is it for?
- Ages 4 to 35 years
- Conditions the study is for
- β-Thalassemia Intermedia
- What is being tested?
- hydroxyurea, L-carnitine and hydroxyurea and hydroxyurea and magnesium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology Research Center of Shiraz University of Medical Sciences
Shiraz, Fars
About this 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.
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 .
- Conditions
- β-Thalassemia Intermedia
- Being tested
- hydroxyurea, L-carnitine and hydroxyurea, hydroxyurea and magnesium chloride, hydroxyurea,L-carnitine and magnesium chloride
- Keywords
- Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyureaDrug
Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).
L-carnitine and hydroxyureaDrug
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).
hydroxyurea and magnesium chlorideDrug
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.
hydroxyurea,L-carnitine and magnesium chlorideDrug
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hydroxyurea Receives: Drug: hydroxyurea |
| 2 | Active comparator | L-carnitine and hydroxyurea Receives: Drug: L-carnitine and hydroxyurea |
| 4 | Active comparator | L-carnitine , magnesium chloride and hydroxyurea Receives: Drug: hydroxyurea,L-carnitine and magnesium chloride |
| 3 | Active comparator | magnesium chloride and hydroxyurea Receives: Drug: hydroxyurea and magnesium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Parameters
Measured: monthly
Secondary outcomes (1)
echocardiographic parameters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJun 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for β-Thalassemia IntermediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mehran Karimi, Full Professor, Principal investigator, Hematology Research Center of Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809042
- Sponsor's protocol ID
- SHaghpanah
- Other IDs
- 3342
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foong WC, Loh CK, Ho JJ, Lau DS. Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.
PubMed 36637054
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00809042
- Acronym / sponsor ID
- SHaghpanah
- Conditions
- β-Thalassemia Intermedia
- Keywords
- Hydroxyurea, magnesium chloride, L-carnitine, β-thalassemia intermedia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: hydroxyureaHydroxyurea |
| 2 | Active comparator | Drug: L-carnitine and hydroxyureaL-carnitine and hydroxyurea |
| 4 | Active comparator | Drug: hydroxyurea,L-carnitine and magnesium chlorideL-carnitine , magnesium chloride and hydroxyurea |
| 3 | Active comparator | Drug: hydroxyurea and magnesium chloridemagnesium chloride and hydroxyurea |
Who may qualify
- Ages
- 4 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Hypothyroidism
- Hypoparathyroidism
- Diabetes mellitus
- Hepatitis B and C
- Positive tests for human immunodeficiency virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxyureaHydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day). | Drug | 1 |
| L-carnitine and hydroxyureaHydroxyurea (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 | 2 |
| hydroxyurea and magnesium chlorideHydroxyurea (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 | 3 |
| hydroxyurea,L-carnitine and magnesium chlorideHydroxyurea (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 | Drug | 4 |
Primary outcome
Hematologic Parameters
Time frame: monthly
1 secondary outcome
echocardiographic parameters
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
- Derived from this study: PubMed 36637054Foong WC, Loh CK, Ho JJ, Lau DS. Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.
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A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehran Karimi, Full Professor principal investigator
Hematology Research Center of Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxyurea, L-carnitine and hydroxyurea and hydroxyurea and magnesium chloride in people with β-Thalassemia Intermedia, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic Parameters (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2008.