Effects of Alpha-Lipoic Acid Supplementation on Cardiovascular Disease Risk Factors in β-Thalassemia Major Patients: A Clinical Trial Crossover Study

AIM: Thalassemia is one of the most common genetic diseases, and cardiovascular disease (CVD) has been considered as the leading cause of mortality in more than 50% of β-thalassemia patients. The aim of this study was to determine the effects of alpha-lipoic acid (ALA) on CVD risk factors in β-thalassemia major patients. METHODS: Twenty β-thalassemia major patients participated in this randomized crossover clinical trial study. Participants were randomly assigned to ALA (600 mg/day) or placebo groups for two 8-wk interventions that were separated by a 3-wk washout period. The CVD risk factors including serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A(2) and trimethylamine N-oxide were measured at the beginning and the end of each intervention phase according to the standard protocol. RESULTS: Serum OPG reduced significantly in the ALA group in all participants (5.38 ± 2.79 to 3.27 ± 2.43 ng/mL, P= .003) and in the male subgroup (5.24 ± 2.56 to 3.13 ± 2.5 ng/mL, P= .015); this reduction was significant in comparison with the placebo group (P= .013). The changes in other CVD risk factors were not significant. CONCLUSION: The results of this study showed that after 8-wk of ALA consumption, the serum OPG reduced significantly in β-thalassemia major patients. Therefore, controlling the serum OPG level with ALA consumption can be an important complementary therapeutic option to prevent the progression of CVD in β-thalassemia major patients.