Magnesium-Zinc-Calcium-Vitamin D Co-supplementation Improves Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial

Data on the effects of magnesium-zinc-calcium-vitamin D co-supplementation on hormonal profiles, biomarkers of inflammation, and oxidative stress among women with polycystic ovary syndrome (PCOS) are scarce. The objective of this study was to assess the effects of magnesium-zinc-calcium-vitamin D co-supplementation on hormonal profiles, biomarkers of inflammation, and oxidative stress in women with PCOS. Sixty PCOS women were randomized into two groups and treated with 100 mg magnesium, 4 mg zinc, 400 mg calcium plus 200 IU vitamin D supplements (n = 30), or placebo (n = 30) twice a day for 12 weeks. Hormonal profiles, biomarkers of inflammation, and oxidative stress were assessed at baseline and at end-of-treatment. After the 12-week intervention, compared with the placebo, magnesium-zinc-calcium-vitamin D co-supplementation resulted in significant reductions in hirsutism (−2.4 ± 1.2 vs. −0.1 ± 0.4, P < 0.001), serum high sensitivity C-reactive protein (−0.7 ± 0.8 vs. +0.2 ± 1.8 mg/L, P < 0.001), and plasma malondialdehyde (−0.4 ± 0.3 vs. +0.2 ± 1.0 μmol/L, P = 0.01), and a significant increase in plasma total antioxidant capacity concentrations (+46.6 ± 66.5 vs. −7.7 ± 130.1 mmol/L, P = 0.04). We failed to find any significant effect of magnesium-zinc-calcium-vitamin D co-supplementation on free androgen index, and other biomarkers of inflammation and oxidative stress. Overall, magnesium-zinc-calcium-vitamin D co-supplementation for 12 weeks among PCOS women had beneficial effects on hormonal profiles, biomarkers of inflammation, and oxidative stress

The Effects of Calcium, Vitamins D and K co-Supplementation on Markers of Insulin Metabolism and Lipid Profiles in Vitamin D-Deficient Women with Polycystic Ovary Syndrome

Background Data on the effects of calcium, vitamins D and K co-supplementation on markers of insulin metabolism and lipid profiles among vitamin D-deficient women with polycystic ovary syndrome (PCOS) are scarce. Objective This study was done to determine the effects of calcium, vitamins D and K co-supplementation on markers of insulin metabolism and lipid profiles in vitamin D-deficient women with PCOS. Methods This randomized double-blind, placebo-controlled trial was conducted among 55 vitamin D-deficient women diagnosed with PCOS aged 18–40 years old. Subjects were randomly assigned into 2 groups to intake either 500 mg calcium, 200 IU vitamin D and 90 µg vitamin K supplements (n=28) or placebo (n=27) twice a day for 8 weeks. Results After the 8-week intervention, compared with the placebo, joint calcium, vitamins D and K supplementation resulted in significant decreases in serum insulin concentrations (−1.9±3.5 vs. +1.8±6.6 µIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (−0.4±0.7 vs. +0.4±1.4, P=0.01), homeostasis model of assessment-estimated b cell function (−7.9±14.7 vs. +7.0±30.3, P=0.02) and a significant increase in quantitative insulin sensitivity check index (+0.01±0.01 vs. −0.008±0.03, P=0.01). In addition, significant decreases in serum triglycerides (−23.4±71.3 vs. +9.9±39.5 mg/dL, P=0.03) and VLDL-cholesterol levels (−4.7±14.3 vs. +2.0±7.9 mg/dL, P=0.03) was observed following supplementation with combined calcium, vitamins D and K compared with the placebo. Conclusion Overall, calcium, vitamins D and K co-supplementation for 8 weeks among vitamin D-deficient women with PCOS had beneficial effects on markers of insulin metabolism, serum triglycerides and VLDL-cholesterol levels

Effects of Long-Term Vitamin D Supplementation on Regression and Metabolic Status of Cervical Intraepithelial Neoplasia: a Randomized, Double-Blind, Placebo-Controlled Trial

We are not aware of any study examining the effects of long term vitamin D administration on regression and metabolic status of patients with cervical intraepithelial neoplasia grade 1 (CIN1). This study was performed to evaluate the effects of long-term vitamin D administration on regression and metabolic status of patients with CIN1. This randomized, double-blind, placebo-controlled trial was performed among 58 women diagnosed with CIN1. CIN1 diagnosis was performed based on specific diagnostic procedures of biopsy, pathological diagnosis, and colposcopy. Patients were randomly allocated into two groups to take 50,000 IU vitamin D3 supplements (n = 29) or placebo (n = 29) every 2 weeks for 6 months. Fasting blood samples were taken at the beginning of the study and end-of-trial to measure related markers. After 6 months of vitamin D administration, greater percentage of women in the vitamin D group had regressed CIN1 (84.6 vs. 53.8%, P = 0.01) than those in the placebo group. Long-term vitamin D supplementation increased serum-25(OH) vitamin D levels in the intervention group compared to the placebo group (+12.3 ± 11.4 vs. -0.1 ± 3.7 ng/mL, P < 0.001). In addition, vitamin D intake led to significant decreases in serum insulin levels (−5.3 ± 7.3 vs. +2.4 ± 5.9 μIU/mL, P < 0.001), homeostasis model of assessment-insulin resistance (−1.2 ± 1.6 vs. +0.5 ± 1.2, P < 0.001), homeostatic model assessment-Beta cell function (P = 0.005) and a significant elevation in quantitative insulin sensitivity check index (+0.03 ± 0.04 vs. -0.007 ± 0.02, P < 0.001) compared with the placebo group. Additionally, significant increases in plasma nitric oxide (NO) (+15.5 ± 10.3 vs. +4.0 ± 13.4 μmol/L, P = 0.001), total antioxidant capacity (TAC) (P = 0.04), total glutathione (GSH) (+11.8 ± 153.5 vs. -294.2 ± 595.1 μmol/L, P = 0.01) and a significant reduction in plasma malondialdehyde (MDA) levels (−0.8 ± 1.0 vs. -0.03 ± 1.4 μmol/L, P = 0.03) were observed following the administration of vitamin D supplements compared with the placebo group. In conclusion, vitamin D3 administration for 6 months among women with CIN1 resulted in its regression and had beneficial effects on markers of insulin metabolism, plasma NO, TAC, GSH and MDA levels. Clinical trial registration numberwww.irct.ir: IRCT201412065623N30

Effects of Selenium Supplementation on Gene Expression Levels of Inflammatory Cytokines and Vascular Endothelial Growth Factor in Patients with Gestational Diabetes

Selenium is known to exert multiple beneficial effects including anti-inflammatory actions. The aim of the study was to evaluate the effects of selenium supplementation on gene expression levels of inflammatory cytokines and vascular endothelial growth factor (VEGF) in women with gestational diabetes (GDM). This randomized double-blind, placebo-controlled trial was carried out among 40 subjects diagnosed with GDM aged 18–40 years old. Subjects were randomly allocated into two groups to receive either 200 μg/day selenium supplements (n = 20) or placebo (n = 20) for 6 weeks. Gene expression of inflammatory cytokines and VEGF were assessed in lymphocytes of GDM women with RT-PCR method. Results of RT-PCR indicated that after the 6-week intervention, compared with the placebo, selenium supplementation downregulated gene expression of tumor necrosis factor alpha (TNF-α) (P = 0.02) and transforming growth factor beta (TGF-β) (P = 0.01), and upregulated gene expression of VEGF (P = 0.03) in lymphocytes of patients with GDM. There was no statistically significant change following supplementation with selenium on gene expression of interleukin (IL)-1β and IL-8 in lymphocytes of subjects with GDM. Selenium supplementation for 6 weeks in women with GDM significantly decreased gene expression of TNF-α and TGF-β, and significantly increased gene expression of VEGF, but did not affect gene expression of IL-1β and IL-8

The effects of vitamin D and probiotic co-supplementation on glucose homeostasis, inflammation, oxidative stress and pregnancy outcomes in gestational diabetes: A randomized, double-blind, placebo-controlled trial

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 &lt; 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 &lt; 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 &lt; 0.001), VLDL- (β �7.51 mg/dL; 95 CI, �10.31, �4.71; P &lt; 0.001), HDL-/total cholesterol ratio (β �0.52; 95 CI, �0.79, �0.24; P &lt; 0.001), high sensitivity C-reactive protein (β �1.80 mg/L; 95 CI, �2.53, �1.08; P &lt; 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 &lt; 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. © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolis

Effects of curcumin on body weight, glycemic control and serum lipids in women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial

Objective: The aim of this study was to evaluate the effect of curcumin on body weight, glycemic control and serum lipids in women suffering from polycystic ovary syndrome (PCOS). Methods: The current randomized, double-blinded, placebo-controlled clinical trial was performed on 60 subjects with PCOS, aged 18�40 years old. Subjects were randomly allocated to take 500 mg/day curcumin (n = 30) or placebo (n = 30) for 12 weeks. Glycemic control and serum lipids were measured at baseline and after the 12-week intervention. Using RT-PCR method, gene expression related to insulin and lipid metabolism was evaluated. Results: Curcumin significantly decreased weight (�0.8 ± 0.9 vs. �0.2 ± 0.8 kg, P = 0.03) and BMI (�0.3 ± 0.4 vs. �0.1 ± 0.3 kg/m2, P = 0.03). Curcumin, compared with the placebo, significantly reduced fasting glucose (β �2.63 mg/dL; 95 CI, �4.21, �1.05; P = 0.002), serum insulin (β �1.16 μIU/mL; 95 CI, �2.12, �0.19; P = 0.02), insulin resistance (β �0.26; 95 CI, �0.48, �0.03; P = 0.02), and significantly increased insulin sensitivity (β 0.006; 95 CI, 0.001, 0.01; P = 0.02). In addition, taking curcumin was associated with a significant reduction in total cholesterol (β �15.86 mg/dL; 95 CI, �24.48, �7.24; P = 0.001), LDL-cholesterol (β �16.09 mg/dL; 95 CI, �25.11, �7.06; P = 0.001) and total-/HDL-cholesterol ratio (β �0.62; 95 CI, �0.93, �0.30; P &lt; 0.001), and a significant increase in HDL-cholesterol levels (β 2.14 mg/dL; 95 CI, 0.36, 3.92; P = 0.01) compared with the placebo. Additionally, curcumin administration up-regulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (P = 0.03) and low-density lipoprotein receptor (LDLR) (P &lt; 0.001) compared with the placebo. Conclusions: Overall, curcumin administration for 12 weeks to women with PCOS had beneficial effects on body weight, glycemic control, serum lipids except triglycerides and VLDL-cholesterol levels, and gene expression of PPAR-γ and LDLR. Registered under Clinical Trials.gov Identifier no. http://www.irct.ir: IRCT20170513033941N50. © 2020 European Society for Clinical Nutrition and Metabolis

Cleft sidedness and congenitally missing teeth in patients with cleft lip and palate patients

Abstract Background The aim of this study was to investigate the prevalence of cleft sidedness, and the number of congenitally missing teeth in regard to cleft type and gender. Methods The charts, models, radiographs, and intraoral photographs of 201 cleft patients including 131 males with the mean age of 12.3 ± 4 years and 70 females with the mean age of 12.6 ± 3.9 years were used for the study. T test, Chi-square, and binomial tests were used for assessment of the data. Results and conclusions One hundred forty-eight of the subjects suffered from cleft lip and palate followed by 41 subjects who suffered from cleft lip and alveolus. Chi-square test did not show any significant difference between the genders. Binomial test showed that left-sided cleft was more predominant in unilateral cleft lip and palate patients (P < 0.001). This study also showed that the upper lateral incisors were the most commonly missing teeth in the cleft area

Vitamin D and probiotic co-supplementation affects mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome

Objective: The aim of this study was to determine the effect of vitamin D and probiotic co-administration on mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome (PCOS). Methods: This randomized, double-blinded, placebo-controlled clinical trial was carried out on 60 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 � 10 9 CFU/day probiotic (n = 30) or placebo (n = 30) for 12 weeks. Results: Vitamin D and probiotic co-supplementation, compared with the placebo, significantly improved beck depression inventory β (difference in the mean of outcomes measures between treatment groups) - 0.58; 95% CI, - 1.15, - 0.02; P = 0.04, general health questionnaire scores (β - 0.93; 95% CI, - 1.78, - 0.08; P = 0.03) and depression, anxiety and stress scale scores (β - 0.90; 95% CI, - 1.67, - 0.13; P = 0.02). Vitamin D and probiotic co-supplementation was associated with a significant reduction in total testosterone (β - 0.19 ng/mL; 95% CI, - 0.28, - 0.10; P &lt; 0.001), hirsutism (β - 0.95; 95% CI, - 1.39, - 0.51; P &lt; 0.001), high-sensitivity C-reactive protein (hs-CRP) (β - 0.67 mg/L; 95% CI, - 0.97, - 0.38; P &lt; 0.001) and malondialdehyde (MDA) levels (β - 0.25 μmol/L; 95% CI, - 0.40, - 0.10; P = 0.001), and a significant increase in total antioxidant capacity (TAC) (β 82.81 mmol/L; 95% CI, 42.86, 122.75; P &lt; 0.001) and total glutathione (GSH) levels (β 40.42 μmol/L; 95% CI, 4.69, 76.19; P = 0.02), compared with the placebo. Conclusions: Overall, the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels. Trial Registration: This study was retrospectively registered in the Iranian website (www.irct.ir) for registration of clinical trials (IRCT20170513033941N37). © 2019 The Author(s)

The effects of magnesium and vitamin e co-supplementation on parameters of glucose homeostasis and lipid profiles in patients with gestational diabetes

Background: Magnesium and vitamin E are known to exert multiple beneficial effects, such as anti-glycemic and anti-lipidemic properties. The aim of this study was to determine the effects of magnesium and vitamin E co-supplementation on metabolic status of women with gestational diabetes (GDM). Methods: This randomized, double-blinded, placebo-controlled trial was conducted among 60 subjects diagnosed with GDM, aged 18-40 years. Subjects were randomly allocated into two groups to receive 250 mg/day magnesium oxide plus 400 IU/day vitamin E supplements or placebo (n = 30 each group) for 6 weeks. Participants' blood samples were taken to determine their metabolic profiles. Results: Subjects who received magnesium plus vitamin E supplements had significantly lower fasting plasma glucose (β - 5.20 mg/dL; 95 CI, - 7.88, - 2.52; P = 0.002), serum insulin levels (β - 2.93 μIU/mL; 95 CI, - 5.68, - 0.18; P = 0.02) and homeostasis model of assessment-insulin resistance (β - 0.78; 95 CI, - 1.42, - 0.14; P = 0.01), and higher quantitative insulin sensitivity check index (β 0.01; 95 CI, 0.005, 0.02; P = 0.002) compared with placebo. In addition, magnesium plus vitamin E supplementation resulted in a significant reduction in serum triglycerides (β - 50.31 mg/dL; 95 CI, - 67.58, - 33.04; P < 0.001), VLDL- (β - 10.06 mg/dL; 95 CI, - 13.51, - 6.60; P < 0.001), total- (β - 26.10 mg/dL; 95 CI, - 41.88, - 10.33; P = 0.004), LDL- (β - 15.20 mg/dL; 95 CI, - 29.50, - 0.91; P = 0.03) and total-/HDL-cholesterol ratio (β - 0.46; 95 CI, - 0.72, - 0.19; P < 0.001) compared with placebo. Magnesium and vitamin E co-supplementation did not affect HDL-cholesterol levels. Conclusions: Overall, magnesium and vitamin E co-supplementation for 6 weeks in women with GDM significantly improved glycemic control and lipid profiles, except for HDL-cholesterol levels. Clinical trial registration number: http://www.irct.ir: IRCT20170513033941N24. © 2018 The Author(s)