The Effects of Folate Supplementation on Regression and Metabolic Status in Endometrial Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled Trial

Background: Data on the effects of folate supplementation on clinical and metabolic status of patients with endometrial hyperplasia (EH) are limited.Objective: This intervention was performed to assess the effects of folate supplementation on clinical and metabolic status of patients with EH.Methods: This randomized, double-blind, placebo-controlled trial was done among 60 women diagnosed with EH. EH diagnosis was conducted based on specific diagnostic procedures of biopsy. Participants were randomly allocated into two groups to take 5 mg folate supplements (n=30) or placebo (n=30) per day for 3 months. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related markers. Results: Compared with the placebo, folate supplementation significantly decreased plasma homocysteine (-4.1±4.8 vs. -0.6±1.1 μmol/L, P<0.001), fasting plasma glucose (-3.4±9.0 vs. +1.1±3.9 mg/dL, P=0.01), serum insulin levels (-2.7±5.4 vs. +0.5±2.3 μIU/mL, P=0.004), homeostasis model of assessment-insulin resistance (-0.7±1.3 vs. +0.2±0.6, P=0.004), serum triglycerides (-11.8±32.3 vs. +5.2±18.5 mg/dL, P=0.01) and VLDL-cholesterol levels (-2.4±6.5 vs. +1.0±3.7 mg/dL, P=0.01), and significantly increased the quantitative insulin sensitivity check index (+0.01±0.03 vs. -0.002±0.01, P=0.02). In addition, significant reductions in serum high sensitivity C-reactive protein (-1.1±2.2 vs. +0.2±1.5 mg/L, P=0.007) and plasma malondialdehyde levels (-0.1±0.3 vs. +0.02±0.3 μmol/L, P=0.04) were seen following supplementation with folate compared with the placebo. We did not see any significant effect of supplementation with folate on regression, other lipid profiles, other biomarkers of inflammation and oxidative. Conclusion: In conclusion, we found that folate administration for 12 weeks at a dosage of 5 mg/day in subjects with EH improved glycemic control, triglycerides, VLDL-cholesterol, hs-CRP and MDA levels, but did not influence regression and other lipid profiles, and biomarkers of inflammatory and oxidative stress.

Keywords:

Folate supplementation , endometrial hyperplasia , metabolic profiles