Mehri Jamilian1, Elaheh Amirani2, Zatollah Asemi3. 1. Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran. 2. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. 3. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_r@yahoo.com.
Abstract
BACKGROUND AND AIMS: This study was designed to assess the effects of combined vitamin D and probiotic supplementation on metabolic status and pregnancy outcomes in women with gestational diabetes (GDM). METHODS: This randomized, double-blind, placebo-controlled clinical trial was performed in 87 women with GDM. Patients were randomly assigned three groups to receive either vitamin D (50,000 IU/every 2 weeks) plus probiotic (8 × 109 CFU/day) (n = 30), probiotic (8 × 109 CFU/day) (n = 29) or placebo (n = 28) for 6 weeks. RESULTS:Vitamin D and probiotic co-supplementation significantly reduced fasting plasma glucose (β -10.99 mg/dL; 95% CI, -14.26, -7.73; P < 0.001), serum insulin levels (β -1.95 μIU/mL; 95% CI, -3.05, -0.84; P = 0.001) and homeostasis model of assessment-insulin resistance (β -0.76; 95% CI, -1.06, -0.45; P < 0.001), and significantly increased the quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.008, 0.03; P = 0.001) compared with the placebo. In addition, vitamin D and probiotic co-supplementation resulted in a significant reduction in triglycerides (β -37.56 mg/dL; 95% CI, -51.55, -23.56; P < 0.001), VLDL- (β -7.51 mg/dL; 95% CI, -10.31, -4.71; P < 0.001), HDL-/total cholesterol ratio (β -0.52; 95% CI, -0.79, -0.24; P < 0.001), high sensitivity C-reactive protein (β -1.80 mg/L; 95% CI, -2.53, -1.08; P < 0.001) and malondialdehyde (β -0.43 μmol/L; 95% CI, -0.77, -0.09; P = 0.01); also, a significant rise in HDL-cholesterol (β 4.09 mg/dL; 95% CI, 1.11, 7.08; P = 0.008) and total antioxidant capacity (TAC) levels (β 97.77 mmol/L; 95% CI, 52.34, 143.19; P < 0.001) were observed compared with the placebo. Vitamin D and probiotic co-supplementation did not change other metabolic parameters. Vitamin D and probiotic co-supplementation significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02) and hs-CRP (P = 0.01), and significantly increased TAC (P = 0.006) and total glutathione levels (P = 0.04) compared with only probiotic group. CONCLUSIONS: In conclusion, vitamin D and probiotic co-supplementation in women with GDM had beneficial effects on metabolic status. This trial was registered at www.irct.ir as IRCT201706075623N119.
RCT Entities:
BACKGROUND AND AIMS: This study was designed to assess the effects of combined vitamin D and probiotic supplementation on metabolic status and pregnancy outcomes in women with gestational diabetes (GDM). METHODS: This randomized, double-blind, placebo-controlled clinical trial was performed in 87 women with GDM. Patients were randomly assigned three groups to receive either vitamin D (50,000 IU/every 2 weeks) plus probiotic (8 × 109 CFU/day) (n = 30), probiotic (8 × 109 CFU/day) (n = 29) or placebo (n = 28) for 6 weeks. RESULTS:Vitamin D and probiotic co-supplementation significantly reduced fasting plasma glucose (β -10.99 mg/dL; 95% CI, -14.26, -7.73; P < 0.001), serum insulin levels (β -1.95 μIU/mL; 95% CI, -3.05, -0.84; P = 0.001) and homeostasis model of assessment-insulin resistance (β -0.76; 95% CI, -1.06, -0.45; P < 0.001), and significantly increased the quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.008, 0.03; P = 0.001) compared with the placebo. In addition, vitamin D and probiotic co-supplementation resulted in a significant reduction in triglycerides (β -37.56 mg/dL; 95% CI, -51.55, -23.56; P < 0.001), VLDL- (β -7.51 mg/dL; 95% CI, -10.31, -4.71; P < 0.001), HDL-/total cholesterol ratio (β -0.52; 95% CI, -0.79, -0.24; P < 0.001), high sensitivity C-reactive protein (β -1.80 mg/L; 95% CI, -2.53, -1.08; P < 0.001) and malondialdehyde (β -0.43 μmol/L; 95% CI, -0.77, -0.09; P = 0.01); also, a significant rise in HDL-cholesterol (β 4.09 mg/dL; 95% CI, 1.11, 7.08; P = 0.008) and total antioxidant capacity (TAC) levels (β 97.77 mmol/L; 95% CI, 52.34, 143.19; P < 0.001) were observed compared with the placebo. Vitamin D and probiotic co-supplementation did not change other metabolic parameters. Vitamin D and probiotic co-supplementation significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02) and hs-CRP (P = 0.01), and significantly increased TAC (P = 0.006) and total glutathione levels (P = 0.04) compared with only probiotic group. CONCLUSIONS: In conclusion, vitamin D and probiotic co-supplementation in women with GDM had beneficial effects on metabolic status. This trial was registered at www.irct.ir as IRCT201706075623N119.
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