Anti-inflammatory and antioxidative effects of thiamin supplements in patients with gestational diabetes mellitus.

OBJECTIVE: The aim of this study was to evaluate the effects of thiamin supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes mellitus (GDM). METHODS: This randomized, double-blind, placebo-controlled trial was conducted among 60 patients with GDM. Patients were randomly allocated into two groups to receive either 100 mg/day thiamin supplements (n = 30) or placebo (n = 30) for 6 weeks. RESULTS: Thiamin supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP) (ß - 0.98 mg/L; 95% CI, -1.54, -0.42; p = .001) and plasma malondialdehyde (MDA) levels (ß - 0.86 µmol/L; 95% CI, -1.15, -0.57; p < .001) when compared with the placebo. In addition, thiamin supplementation downregulated gene expression of tumor necrosis factor-alpha (TNF-α) (p = .002) in peripheral blood mononuclear cells of patients with GDM. Thiamin supplementation did not affect other biomarkers of inflammation and oxidative stress. CONCLUSION: Overall, thiamin supplementation for 6 weeks to patients with GDM significantly reduced hs-CRP and MDA levels, and gene expression of TNF-α, but did not affect other biomarkers of inflammation and oxidative stress. CLINICAL TRIAL REGISTRATION NUMBER: Clinical Trials.govIdentifier no. http://www.irct.ir: IRCT20170513033941N58.

The effects of n-3 fatty acids from flaxseed oil on genetic and metabolic profiles in patients with gestational diabetes mellitus: a randomised, double-blind, placebo-controlled trial.

The present study was performed to evaluate the effects of n-3 fatty acids from flaxseed oil on genetic and metabolic profiles in patients with gestational diabetes mellitus (GDM). This randomised, double-blind, placebo-controlled clinical trial was performed in sixty women with GDM. Participants were randomly divided into two groups to intake either 2 × 1000 mg/d n-3 fatty acids from flaxseed oil containing 400 mg α-linolenic acid in each capsule (n 30) or placebo (n 30) for 6 weeks. n-3 Fatty acid intake up-regulated PPAR-γ (P < 0·001) and LDL receptor (P = 0·004) and down-regulated gene expression of IL-1 (P = 0·002) and TNF-α (P = 0·001) in peripheral blood mononuclear cells of subjects with GDM. In addition, n-3 fatty acid supplementation reduced fasting plasma glucose (P = 0·001), insulin levels (P = 0·001) and insulin resistance (P < 0·001) and increased insulin sensitivity (P = 0·005) when compared with the placebo. Additionally, n-3 fatty acid supplementation was associated with a decrease in TAG (P < 0·001), VLDL-cholesterol (P < 0·001), total cholesterol (P = 0·01) and total cholesterol:HDL-cholesterol ratio (P = 0·01) when compared with placebo. n-3 Fatty acid administration was also associated with a significant reduction in high-sensitivity C-reactive protein (P = 0·006) and malondialdehyde (P < 0·001), and an increase in total nitrite (P < 0·001) and total glutathione levels (P = 0·006) when compared with the placebo. n-3 Fatty acid supplementation for 6 weeks to women with GDM had beneficial effects on gene expression related to insulin, lipid and inflammation, glycaemic control, lipids, inflammatory markers and oxidative stress.

Clinical and Metabolic Response to Vitamin D Supplementation in Endometrial Hyperplasia: a Randomized, Double-Blind, Placebo-Controlled Trial.

There was inconsistent evidence showing that vitamin D intake may be associated with reduced cancer risk due to optimized metabolic profile and reduced oxidative stress. However, we are not aware of any study evaluating the effects of vitamin D supplementation on clinical response and metabolic status of patients with endometrial hyperplasia (EH). This research was done to evaluate the effects of vitamin D supplementation on clinical response and metabolic status of patients with EH. This randomized, double-blind, placebo-controlled trial was conducted among 60 women diagnosed with EH. EH diagnosis was made based on specific diagnostic procedures of biopsy. Participants were randomly assigned into two groups to intake either 50,000 IU vitamin D3 supplements (n = 30) or placebo (n = 30) every 2 weeks for 12 weeks. After the 12-week intervention, compared with the placebo, vitamin D supplementation increased serum-25(OH) vitamin D levels (+12.0 ± 10.4 vs. +1.9 ± 7.1 ng/mL, P < 0.001). In addition, vitamin D administration was associated with significant decreases in fasting plasma glucose (FPG) (-1.6 ± 7.0 vs. +2.1 ± 6.1 mg/dL, P = 0.03), serum insulin levels (-0.8 ± 1.9 vs. +1.1 ± 3.5 µIU/mL, P = 0.01), homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.2 ± 0.6 vs. +0.3 ± 0.8, P = 0.01), and a significant increase in the quantitative insulin sensitivity check index (QUICKI) (+0.003 ± 0.01 vs. -0.01 ± 0.02, P = 0.02) compared with the placebo. Additionally, a significant decrease in serum high-sensitivity C-reactive protein (hs-CRP) (-1.9 ± 2.8 vs. -0.003 ± 2.0 µg/mL, P = 0.003) and a significant rise in plasma total antioxidant capacity (TAC) values (+62.5 ± 53.5 vs. +7.5 ± 34.1 mmol/L, P < 0.001) were observed following supplementation with vitamin D compared with the placebo. In conclusion, vitamin D3 supplementation for 12 weeks among women with EH had beneficial effects on glucose metabolism, serum hs-CRP, and plasma TAC concentrations. In addition, vitamin D may have played an indirect role in reducing complications of EH due to its effect on improved glycemic control, hs-CRP, and TAC concentrations.

Calcium-Vitamin D Co-supplementation Affects Metabolic Profiles, but not Pregnancy Outcomes, in Healthy Pregnant Women.

BACKGROUND: Pregnancy is associated with unfavorable metabolic profile, which might in turn result in adverse pregnancy outcomes. The current study was designed to evaluate the effects of calcium plus Vitamin D administration on metabolic status and pregnancy outcomes in healthy pregnant women. METHODS: This randomized double-blind placebo-controlled clinical trial was performed among 42 pregnant women aged 18-40 years who were at week 25 of gestation. Subjects were randomly allocated to consume either 500 mg calcium-200 IU cholecalciferol supplements (n = 21) or placebo (n = 21) for 9 weeks. Blood samples were obtained at the onset of the study and after 9-week trial to determine related markers. Post-delivery, the newborn's weight, length, and head circumference were measured during the first 24 h after birth. RESULTS: Consumption of calcium-Vitamin D co-supplements resulted in a significant reduction of serum high-sensitivity C-reactive protein levels compared with placebo (-1856.8 ± 2657.7 vs. 707.1 ± 3139.4 µg/mL, P = 0.006). We also found a significant elevation of plasma total antioxidant capacity (89.3 ± 118.0 vs. -9.4 ± 164.9 mmol/L, P = 0.03), serum 25-hydroxyvitamin D (2.5 ± 3.5 vs. -1.7 ± 1.7 ng/mL, P < 0.0001), and calcium levels (0.6 ± 0.6 vs. -0.1 ± 0.4 mg/dL, P < 0.0001). The supplementation led to a significant decrease in diastolic blood pressure (-1.9 ± 8.3 vs. 3.1 ± 5.2 mmHg, P = 0.02) compared with placebo. No significant effect of calcium-Vitamin D co-supplements was seen on other metabolic profiles. We saw no significant change of the co-supplementation on pregnancy outcomes as well. CONCLUSIONS: Although calcium-Vitamin D co-supplementation for 9 weeks in pregnant women resulted in improved metabolic profiles, it did not affect pregnancy outcomes.

Zinc supplementation and the effects on metabolic status in gestational diabetes: A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To the best of our knowledge, no reports are available indicating the effects of zinc supplementation on metabolic status in women with gestational diabetes (GDM). This study was designed to determine the effects of zinc supplementation on glucose homeostasis parameters and lipid concentrations in GDM women. METHODS: This randomized, double-blind, placebo-controlled trial was performed among 58 women diagnosed with GDM, primigravida and aged 18-40years old. Patients were randomly divided into two groups to receive 233mg zinc gluconate (containing 30mg zinc) supplements (n=29) or placebo (n=29) per day for 6weeks. Fasting blood samples were taken at the beginning and end of the trial to quantify glucose, insulin and lipid concentrations. RESULTS: Patients who received zinc supplements had significantly higher serum zinc concentrations (+6.9±13.2 vs. -1.5±16.5mg/dL, P=0.03) than those received the placebo. In addition, zinc-supplemented patients had reduced fasting plasma glucose (FPG) (-6.6±11.2 vs. +0.6±6.7mg/dL, P=0.005), serum insulin levels (-1.3±6.6 vs. +6.6±12.2µIU/mL, P=0.003), homeostasis model of assessment-insulin resistance (HOMA-IR) (-0.5±1.6 vs. +1.5±2.7, P=0.001), homeostatic model assessment-Beta cell function (HOMA-B) (-0.7±25.0 vs. +26.5±49.5, P=0.01) and increased quantitative insulin sensitivity check index (QUICKI) (+0.01±0.01 vs. -0.01±0.02, P=0.004) compared with the placebo. Additionally, significant differences in serum triglycerides (+13.6±61.4 vs. +45.9±36.5mg/dL, P=0.01) and VLDL-cholesterol concentrations (+2.7±12.3 vs. +9.2±7.3mg/dL, P=0.01) were observed following the administration of zinc supplements compared with the placebo.We did not observe any significant effects of taking zinc supplements on other lipid profiles. CONCLUSIONS: Taken together, 30mg zinc supplementation per day for 6weeks among GDM women had beneficial effects on metabolic profiles.

Effect of multivitamin versus multivitamin-mineral supplementation on metabolic profiles and biomarkers of oxidative stress in pregnant women: a double-blind randomized clinical trial.

OBJECTIVE: This study was designed to determine the favorable effects of received multivitamin versus multivitamin-mineral supplements on metabolic profiles and biomarkers of oxidative stress among Iranian pregnant women. METHODS: This double-blind randomized-controlled clinical trial was conducted among 70 pregnant women, primigravida, aged 18-35 years old between 16 and 37 weeks gestation. Subjects were randomly assigned to receive either the multivitamin (n = 35) or multivitamin-mineral supplements (n = 35) for 20 weeks. Fasting blood samples were taken at baseline and after a 20-week intervention to measure lipid profiles and biomarkers of oxidative stress. RESULTS: After 20 weeks of intervention, multivitamin-mineral supplementation resulted in a significant difference on serum triglycerides levels (changes from baseline in multivitamin-mineral group: +6.1 versus in multivitamin group: +45.9 mg/dl, p = 0.04) compared with the multivitamin group. In addition, increased concentrations of serum HDL-cholesterol (changes from baseline in multivitamin-mineral group: +0.1 versus in multivitamin group: -7.4 mg/dl, p = 0.02) and total glutathione (GSH) levels (changes from baseline in multivitamin-mineral group: +151.09 versus in multivitamin group: -116.21 µmol/l, p = 0.003) were also seen in the multivitamin-mineral group compared with the multivitamin group. CONCLUSION: Supplementation of multivitamin-mineral compared to multivitamin supplementation for 20 weeks during pregnancy had beneficial effects on triglycerides, HDL-cholesterol and GSH levels.

Multivitamin Versus Multivitamin-mineral Supplementation and Pregnancy Outcomes: A Single-blind Randomized Clinical Trial.

BACKGROUND: Increased requirement and decreased dietary intakes of micronutrients during pregnancy might affect maternal health and pregnancy outcomes. This study was aimed to examine the effects of two types of multiple micronutrient supplementations on pregnancy outcomes in Kashan, Iran. METHODS: In a randomized single-blind controlled clinical trial, 104 primigravid singleton pregnant women aged 18-30 years were randomly assigned to receive either a multivitamin (n = 51) or a multivitamin-mineral (n = 53) supplements for 20 weeks. Participants consumed supplements once a day at week 16 of gestation. Maternal anthropometric data as well as newborn's weight, height, head circumference and 5-min Apgar score were also determined. Independent samples t-test was used for comparing between-group means. Multivariate linear regression analysis was used to identify determinants of newborn's weight, height and head circumference. RESULTS: Women taking multivitamin-mineral supplements gained marginally less weight until week 28 than those taking multivitamin supplements (weight at week 28 of gestation: 67.5 ± 11.4 vs. 71.6 ± 10.3 kg, P = 0.06). Mean body mass index at week 28 (25.8 ± 4.0 vs. 28.4 ± 3.7 kg/m(2), P = 0.001) as well as at delivery (28.0 ± 3.9 vs. 30.1 ± 3.8 kg/m(2), P = 0.006) was lower among women taking multivitamin-mineral supplements than those taking multivitamin supplements. Although no significant difference was seen in newborns' height and Apgar score between the two groups, mean birth weight (3.3 ± 0.4 vs. 3.1 ± 0.4 kg, P = 0.04) and head circumference (35 ± 1.4 vs. 34 ± 1.3 cm, P < 0.0001) of the infants whose mothers receiving multivitamin-mineral supplements were higher than those whose mothers received multivitamins. Multivitamin-mineral use by pregnant women was a significant predictor of infants' weight (ß =0.191, P = 0.03) and head circumference (ß =0.907, P = 0.005). CONCLUSIONS: In conclusion, we found that birth weight and head circumference was increased in infants whose mothers received multivitamin-mineral supplements for 5 months during pregnancy compared with infants whose mothers received multivitamin supplements.

Effect of Multivitamin-Mineral versus Multivitamin Supplementation on Maternal, Newborns' Biochemical Indicators and Birth Size: A Double-Blind Randomized Clinical Trial.

OBJECTIVE: Micronutrient deficiency during pregnancy is associated with several complications. This study was designed to determine the effects of received multivitamin-mineral vs. multivitamin supplements on maternal, newborns' biochemical indicators, and birth size. METHODS: This double-blind randomized-controlled clinical trial was conducted among 48 Iranian pregnant women, primigravida, aged 18-35 years old in their second and third trimester from December 2011 to September 2012. Subjects were randomly assigned to receive either the multivitamin-mineral (n=24) or multivitamin supplements (n=24) for 20 weeks. Fasting blood samples were taken at baseline and after a 20-week intervention of pregnant women as well as umbilical cord blood of the babies immediately after delivery to measure serum calcium, vitamin D, iron, magnesium, zinc and biomarkers of oxidative stress including plasma total antioxidant capacity and total glutathione. RESULTS: Multivitamin-mineral compared to multivitamin supplementation resulted in a significant increase in maternal serum calcium (0.5 vs. -0.1 mg/dL, p=0.04) and magnesium levels (0.1 vs. -0.2 mg/dL, p<0.001). Furthermore, mean plasma total glutathione levels (1791 ± 566 vs. 1434 ± 622 µmol/l, p=0.04) of the newborns whose mothers received multivitamin-mineral were higher than those whose mothers received multivitamin supplements. CONCLUSIONS: Overall, multivitamin-mineral compared to multivitamin supplementation for 20 weeks during pregnancy resulted in a significant increase in maternal serum calcium and magnesium levels as well as a significant elevation of newborn plasma total glutathione levels.

Vitamin D supplementation affects serum high-sensitivity C-reactive protein, insulin resistance, and biomarkers of oxidative stress in pregnant women.

Unfavorable metabolic profiles and oxidative stress in pregnancy are associated with several complications. This study was conducted to determine the effects of vitamin D supplementation on serum concentrations of high-sensitivity C-reactive protein (hs-CRP), metabolic profiles, and biomarkers of oxidative stress in healthy pregnant women. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 pregnant women aged 18-40 y old at 25 wk of gestation. Participants were randomly assigned to receive either 400 IU/d cholecalciferol supplements (n = 24) or placebo (n = 24) for 9 wk. Fasting blood samples were taken at study baseline and after 9 wk of intervention to quantify serum concentrations of hs-CRP, lipid concentrations, insulin, and biomarkers of oxidative stress. After 9 wk of intervention, the increases in serum 25-hydroxyvitamin D and calcium concentrations were greater in the vitamin D group (+3.7 µg/L and +0.20 mg/dL, respectively) than in the placebo group (-1.2 µg/L and -0.12 mg/dL, respectively; P < 0.001 for both). Vitamin D supplementation resulted in a significant decrease in serum hs-CRP (vitamin D vs. placebo groups: -1.41 vs. +1.50 µg/mL; P-interaction = 0.01) and insulin concentrations (vitamin D vs. placebo groups: -1.0 vs. +2.6 µIU/mL; P-interaction = 0.04) and a significant increase in the Quantitative Insulin Sensitivity Check Index score (vitamin D vs. placebo groups: +0.02 vs. -0.02; P-interaction = 0.006), plasma total antioxidant capacity (vitamin D vs. placebo groups: +152 vs. -20 mmol/L; P-interaction = 0.002), and total glutathione concentrations (vitamin D vs. placebo groups: +205 vs. -32 µmol/L; P-interaction = 0.02) compared with placebo. Intake of vitamin D supplements led to a significant decrease in fasting plasma glucose (vitamin D vs. placebo groups: -0.65 vs. -0.12 mmol/L; P-interaction = 0.01), systolic blood pressure (vitamin D vs. placebo groups: -0.2 vs. +5.5 mm Hg; P-interaction = 0.01), and diastolic blood pressure (vitamin D vs. placebo groups: -0.4 vs. +3.1 mm Hg; P-interaction = 0.01) compared with placebo. In conclusion, vitamin D supplementation for 9 wk among pregnant women has beneficial effects on metabolic status.

Effect of calcium-vitamin D supplementation on metabolic profiles in pregnant women at risk for pre-eclampsia: a randomized placebo-controlled trial.

Increased metabolic profiles during pregnancy are associated with an increased risk of maternal and neonatal morbidity and remain a significant medical challenge. To our knowledge, no reports are available indicating the effects of calcium-vitamin D supplementation on metabolic profiles among pregnant women at risk for pre-eclampsia. This study was designed to determine the effects of consumption calcium-vitamin D supplements on metabolic profiles among Iranian pregnant women at risk for pre-eclampsia. This randomized single-blind controlled clinical trial was performed among 49 pregnant women at risk for pre-eclampsia, primigravida, aged 18-35 year old who were carrying singleton pregnancy at their third trimester. Subjects were randomly assigned to consume the placebo (n = 25) or calcium-vitamin D supplements (n = 24) for 9 weeks. Calcium-vitamin D supplements were containing 500 mg carbonate calcium plus 200 IU vitamin D3. Fasting blood samples were taken at baseline and after 9 week intervention to measures of Fasting Plasma Glucose (FPG) and serum lipid profiles. Consumption of calcium-vitamin D supplements resulted in decreased FPG and serum triglycerides levels as compared to the placebo (-9.1 vs. 0.5 mg dL(-1); p = 0.03, -11.7 vs. 49.9 mg dL(-1); p = 0.001, respectively). No significant differences were found comparing calcium-vitamin D supplements and the placebo in terms of their effect on serum total-, HDL-, LDL-cholesterol levels. Within-group differences in the placebo group revealed a significant increase in serum triglycerides levels (+49.9 mg dL(-1), p < 0.0001). In conclusion, consumption of calcium-vitamin D supplements for 9 weeks during pregnancy among pregnant women at risk for pre-eclampsia resulted in decreased FPG and serum triglycerides levels as compared to the placebo group, but could not affect serum total-, HDL-, LDL-cholesterol levels.