Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation

Not Applicable

Recruiting

• Conditions: Thalassemia Major
• Interventions: Dietary Supplement: Taurine; Other: Placebo

• Registration Number: NCT04291352
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Start: 2020-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-30
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurine	Taurine	675mg taurine four times daily
Placebo	Placebo	placebo four times daily

Primary Outcome Measures

Name	Time	Method
Cardiac iron overload	12 months	Differences in ratio (T2\* at year 1)/(T2\* at baseline) between the taurine and standard chelation therapy arm

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	12 months	Differences in LVEF between the taurine and standard chelation therapy arm
C-reactive protein	12 months	Differences in CRP between the taurine and standard chelation therapy arm
Reduced glutathione	12 months	Differences in GSH between the taurine and standard chelation therapy arm
Blood taurine level	12 months	Differences in blood taurine level between the taurine and standard chelation therapy arm
Plasma MDA	12 months	Differences in Plasma MDA between the taurine and standard chelation therapy arm
Interleukin-6	12 months	Differences in IL-6 between the taurine and standard chelation therapy arm

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada