Effects of alpha lipoic acid on iron overload, lipid profile and oxidative stress indices in β-thalassemia major patients: A cross-over randomised controlled clinical trial.

AIMS β-Thalassemia major (β-TM) is associated with iron overload, abnormal lipid levels and oxidative stress. Alpha lipoic acid (ALA) showed anti-oxidant and iron chelating properties, but its effect in β-TM patients is unclear. We investigated the effects of ALA on iron levels, lipid profile and oxidative stress. METHODS In this cross-over randomised clinical trial, 26 β-TM patients were assigned to receive 600 mg/d ALA or placebo (corn starch), for 8 weeks with a 21-days washout period. Serum ferritin, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), LDL-C/HDL-C, total antioxidant capacity, malondialdehyde (MDA) and MDA/LDL-C were assessed at baseline and the end of each intervention phase. RESULTS Twenty-two patients completed the study. Serum ferritin (P = .004), MDA (P = .025) and MDA/LDL-C ratio (P =.002) were decreased and HDL-C (P =.035) increased significantly during ALA consumption. In comparison with placebo, ALA decreased the serum ferritin significantly (P = .02). Also, the changes in serum ferritin between ALA and placebo (-123.1 ± 40.0 vs -34.3 ± 21.0, P =.03) was significant in women subgroup. ALA had no significant effects on the other biomarkers. CONCLUSION The results of this study indicated that supplementation with 600 mg/d ALA may decrease serum ferritin in β-TM. Further studies are needed to confirm the findings.