NCT00809042

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

5 months

First QC Date

December 15, 2008

Last Update Submit

December 15, 2008

Conditions

β-Thalassemia Intermedia

Keywords

Hydroxyureamagnesium chlorideL-carnitineβ-thalassemia intermedia

Outcome Measures

Primary Outcomes (1)

  • Hematologic Parameters

    monthly

Secondary Outcomes (1)

  • echocardiographic parameters

    6 months

Study Arms (4)

1

EXPERIMENTAL

Hydroxyurea

Drug: hydroxyurea

2

ACTIVE COMPARATOR

L-carnitine and hydroxyurea

Drug: L-carnitine and hydroxyurea

4

ACTIVE COMPARATOR

L-carnitine , magnesium chloride and hydroxyurea

Drug: hydroxyurea,L-carnitine and magnesium chloride

3

ACTIVE COMPARATOR

magnesium chloride and hydroxyurea

Drug: hydroxyurea and magnesium chloride

Interventions

hydroxyureaDRUG

Hydroxyurea (500 mg capsules) was administered in a single dose at a mean of 10/mg/kg/day (range8-12mg/kg/day).

1
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).

2
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.

3
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

4

Eligibility Criteria

Age4 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology Research Center of Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (1)

  • 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.

    PMID: 36637054DERIVED

MeSH Terms

Interventions

HydroxyureaCarnitineMagnesium Chloride

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsMagnesium Compounds

Study Officials

  • Mehran Karimi, Full Professor

    Hematology Research Center of Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 16, 2008

Study Start

June 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

IR(1)