Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypothesis: Taurine, in combination with standard iron chelation therapy, is more effective than chelation therapy alone in reducing cardiac iron overload, oxidative stress and cardiac damage in β-Thalassemia.
Protocol: Sixty subjects with transfusion dependent β-Thalassemia receiving deferasirox iron chelation therapy will be recruited and randomized in a 1:1 ratio to either (1) placebo and continuation of their iron chelation or (2) a combination of iron chelation plus taurine. Transfusion and safety visits will be scheduled monthly with clinical/biochemical assessment visits every three months. The efficacy of taurine combined with standard chelation therapy will be assessed at baseline and 12 months posttreatment by both cardiac T2*MRI, and cardiac function. The recruitment period is projected to be 12 months from initiation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurine | Experimental | 675mg taurine four times daily |
|
| Placebo | Placebo Comparator | placebo four times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine | Dietary Supplement | 675mg taurine four times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac iron overload | Differences in ratio (T2* at year 1)/(T2* at baseline) between the taurine and standard chelation therapy arm | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction | Differences in LVEF between the taurine and standard chelation therapy arm | 12 months |
| Blood taurine level | Differences in blood taurine level between the taurine and standard chelation therapy arm |
Not provided
Participant inclusion criteria
Participants who meet all of the following criteria will qualify for entry into the study:
Participant exclusion criteria
Participants who meet any of the following criteria will be excluded from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anneliesse Justiniano | Contact | 416-340-4800 | 6729 | anneliesse.justiniano@uhn.ca |
| Red blood Cell Disorders Clinical Trials Program | Contact | rbcd.clinicaltrials@uhn.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
Undetermined at this time
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
Not provided
Not provided
| ID | Term |
|---|---|
| D013654 | Taurine |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
Prospective, double-blind, randomized control trial. Subjects are randomized to receive either taurine or placebo in addition to their standard chelation regimen for a 12 month period.
Not provided
Not provided
Both taurine and placebo powder inside the capsules are a white crystalline, odorless powder. The powder is loaded into clear, vegetarian, odorless capsules. Placebo and Investigational Product capsules will be packaged in 500 cc HDPE bottles.
| Placebo |
| Other |
placebo four times daily |
|
| 12 months |
| C-reactive protein | Differences in CRP between the taurine and standard chelation therapy arm | 12 months |
| Interleukin-6 | Differences in IL-6 between the taurine and standard chelation therapy arm | 12 months |
| Plasma MDA | Differences in Plasma MDA between the taurine and standard chelation therapy arm | 12 months |
| Reduced glutathione | Differences in GSH between the taurine and standard chelation therapy arm | 12 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009930 |
| Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |