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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
675mg taurine four times daily
placebo four times daily
University Health Network
Toronto, Ontario, Canada
RECRUITINGCardiac iron overload
Differences in ratio (T2\* at year 1)/(T2\* at baseline) between the taurine and standard chelation therapy arm
Time frame: 12 months
Left ventricular ejection fraction
Differences in LVEF between the taurine and standard chelation therapy arm
Time frame: 12 months
Blood taurine level
Differences in blood taurine level between the taurine and standard chelation therapy arm
Time frame: 12 months
C-reactive protein
Differences in CRP between the taurine and standard chelation therapy arm
Time frame: 12 months
Interleukin-6
Differences in IL-6 between the taurine and standard chelation therapy arm
Time frame: 12 months
Plasma MDA
Differences in Plasma MDA between the taurine and standard chelation therapy arm
Time frame: 12 months
Reduced glutathione
Differences in GSH between the taurine and standard chelation therapy arm
Time frame: 12 months
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