Effects of L-Carnitine and Coenzyme Q10 Supplementation on Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia: A Randomized, Controlled, Clinical Trial.

The prevalence of benign prostatic hyperplasia (BPH) and its associated lower urinary tract symptoms (LUTS) increases with age. Considering that BPH drug treatment is associated with complications, this study aimed to investigate the effects of L-carnitine (LC) and Coenzyme Q10 (CoQ10) supplementation as an adjunct therapy to finasteride in the management of LUTS in older men affected with BPH. Fifty eligible volunteers (25 per group) were randomly assigned to either intervention (finasteride + LC and CoQ10 supplements) or control (finasteride + placebo) groups. International prostate symptom score (IPSS), international index of erectile function (IIEF), quality of life index (QoL), as well as serum levels of Prostate-specific antigen (PSA), were assessed. Prostate ultrasound evaluation was also performed, before and after 8 wk of intervention. Supplementation with LC and CoQ10 led to a significant decrease in prostate volume (p < 0.001) as well as a significant increase in IIEF (p < 0.001), compared to the control group. However, there were no significant between-group differences in IPSS (p = 0.503), QoL scores (p = 0.339), and PSA levels (p = 0.482). CoQ10 and LC supplements might be beneficial in combination with standard therapies in the management of BPH and its related complications.

The effects of zinc supplementation on the metabolic factors in patients with non-alcoholic fatty liver disease: a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is associated with metabolic factors including obesity, dyslipidemia, insulin resistance, oxidative stress, and elevated inflammatory factors. Zinc (Zn) supplementation has been investigated as a potential adjunctive therapy in managing NAFLD outcomes. METHODS: In this randomized, double-blinded, controlled clinical trial, 50 overweight or obese participants with NAFLD were randomized into 2 groups of 25 and received either 30 mg of daily Zn or a placebo for 8 weeks. Both groups were invited to follow a balanced energy-restricted diet and physical activity recommendations. RESULTS: Based on the between-group comparison, Zn supplementation caused a significant increase in the Zn level (P < 0.001) and a significant decrease in weight (P = 0.004), body mass index (BMI) (P = 0.002), waist circumference (P = 0.010), aspartate transaminase (AST) (P = 0.033), total cholesterol (TC) (P = 0.045), and low-density lipoprotein cholesterol (LDL-C) (P = 0.014), but it had no significant effect on alanine transaminase (ALT), fasting blood sugar (FBS), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), high-density lipoprotein (HDL), triglyceride (TG), high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), and total antioxidant capacity (TAC) (P > 0.05). CONCLUSION: The results of the present study indicated that 8-week supplementation of 30 mg daily Zn may increase the Zn serum level and decline anthropometric parameters, AST, TC, and LDL-C in NAFLD patients, so further research is suggested in the future. TRIAL REGISTRATION: The trial was retrospectively registered at IRCT.ir as IRCT20191015045113N1 (December/8/2019).

Effects of probiotic and magnesium co-supplementation on mood, cognition, intestinal barrier function and inflammation in individuals with obesity and depressed mood: A randomized, double-blind placebo-controlled clinical trial.

Background: The co-occurrence of obesity and mood impairments named as "metabolic mood syndrome" (MMS) is often neglected in the obesity management. This study aimed to evaluate effects of Probio-Tec ®BG-VCap-6.5 and magnesium co-supplementation on mood, cognition, intestinal barrier function and serum C reactive protein (CRP) levels in participants with obesity and depressed mood. Design: Seventy-four eligible participants were randomly allocated to either Probio-Tec®BG-VCap-6.5 [containing Lactobacillus rhamnosus (LGG®) and Bifidobacterium animalis subsp. Lactis (BB-12®)] + Magnesium chloride or placebo for 9 weeks. Sociodemographic data were collected in the beginning. Anthropometric, dietary and physical activity (PA) assessments were carried out. Beck Depression Inventory-II (BDI-II) and Montreal Cognitive Assessment (MoCA) scores were assessed through validated questionnaires. Fasting plasma zonulin, lipopolysaccharide (LPS) and (CRP) were measured by ELIZA kits. Results: Of seventy-four participants (mean age 37.51 ± 8.10), 52 completed the study. Changes in serum LPS and zonulin were not different significantly between groups (-3.04 ± 44.75 ng/dl, 0.11 ± 5.13, ng/dl, p > 0.05 for LPS and 1.40 ± 48.78 ng/dl, -0.17 ± 6.60, p > 0.05 for zonulin, respectively). CRP levels reduced significantly in intervention group compared to placebo [-474.75 (-1,300.00, -125.00) mg/l vs. 175.20 (-957.75, 1,683.25) mg/l, p = 0.016]. Changes in BDI-II and MoCA scores were not significantly different between intervention (-7.13 ± 5.67, 1.20 ± 2.16, respectively) and placebo (-5.42 ± 6.71, 1.94 ± 1.86, respectively) groups (p > 0.05). Conclusion: Nine weeks of probiotic and magnesium co-supplementation resulted in decreased CRP levels as an indicator of inflammatory state with no significant effects on mood, cognition and intestinal integrity in individuals with obesity and depressed mood.

Safflower (Carthamus tinctorius L.) oil could improve abdominal obesity, blood pressure, and insulin resistance in patients with metabolic syndrome: A randomized, double-blind, placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Carthamus tinctorius L. (Safflower) has been widely recommended to treat metabolic disorders in traditional herbal medicine in Persia, China, Korea, Japan, and other East-Asian countries. The anti-hypercholesterolemic and antioxidant effects of this plant have been well documented, but its protective effects against Metabolic Syndrome (MetS) have not been fully illustrated. AIM OF THE STUDY: The present study aimed to evaluate the effects of safflower oil on MetS risk factors. MATERIALS AND METHODS: In this randomized, double-blind, placebo-controlled clinical trial, 67 patients with MetS were administered either divided 8 g safflower oil or placebo daily for 12 weeks. All patients were advised to follow their previous diets and physical activities. RESULTS: Safflower oil resulted in a significant reduction in waist circumference (-2.42 ± 3.24 vs. 0.97 ± 2.53, p<0.001), systolic blood pressure (-8.80 ± 9.77 vs. -2.26 ± 8.56, p = 0.021), diastolic blood pressure (-3.53 ± 7.52 vs. -0.70 ± 6.21, p = 0.041), fasting blood sugar (-5.03 ± 10.62 vs. 2.94 ± 7.57, p = 0.003), and insulin resistance (-0.59 ± 1.43 vs. 0.50 ± 1, p = 0.012), but an increase in adiponectin level (0.38 ± 0.99 vs. -0.09 ± 0.81, p = 0.042) in the treatment group in comparison to the placebo group. The results revealed a direct relationship between leptin level and Body Mass Index (BMI) in both groups (p<0.001). In addition, increase in BMI resulted in a non-significant decrease in adiponectin level in both groups. Moreover, no significant difference was observed between the two groups regarding lipid profiles, leptin serum level, serum creatinine concentration, and other outcomes. CONCLUSION: Safflower oil without lifestyle modification improved abdominal obesity, blood pressure, and insulin resistance in patients with MetS.

Effect of hydroalcoholic extract of Berberis integerrima and resveratrol on ovarian morphology and biochemical parameters in Letrozole-induced polycystic ovary syndrome rat model: An experimental study.

BACKGROUND: Resveratrol and Berberis integerrima (B. integerrima) are known to be natural antioxidants and regulators of human metabolism. However, the effects of resveratrol and B. integerrima on the ovarian morphology in polycystic ovary syndrome (PCOS) are not obvious. OBJECTIVE: This study aimed to determine the effect of the hydroalcoholic extract of B. integerrima in combination with resveratrol on some biochemical parameters and ovarian morphology in the letrozole-induced PCOS rat. MATERIALS AND METHODS: Seventy adult female Sprague-Dawley rats aged 10-12 weeks weighing 200 ± 20 gr were randomly divided into seven groups (n = 10/each). Group I): normal; Group II): vehicle; Group III): letrozole-induced PCOS 1 mg/kg letrozole orally, rats receiving 1 cc normal saline orally; Group IV): PCOS + receiving 150 mg/kg metformin orally; Group V): PCOS + receiving 20 mg/kg resveratrol orally; Group VI): PCOS + 3 gr/kg barberry orally; and Group VII): PCOS + receiving 3 gr/kg barberry and 20 mg/kg resveratrol orally. All animals were followed-up for 63 days. The biochemical parameters and histological assessments of ovaries were performed. RESULTS: Resveratrol alone and/or in combination with B. integerrima treatment in rats led to a significant decrease in low-density lipoprotein, triglyceride, malondialdehyde, and tumor necrosis factor-alpha concentrations (p = 0.02). The groups IV, V, VI, and VII showed a decrease in insulin resistance and an increase in the superoxide dismutase, total antioxidant capacity, and high-density lipoprotein (p = 0.01). No significant difference was observed between the level of serum glucose in the treatment groups. Number of cystic follicles had a significant decrease in barberry, resveratrol, and their combination groups (p < 0.001). CONCLUSION: Resveratrol, B. integerrima, and their combination as natural products with fewer side effects might be effective as an alternative medicine in treatment of PCOS.

Fortified whey beverage for improving muscle mass in chronic obstructive pulmonary disease: a single-blind, randomized clinical trial.

BACKGROUND: The development of effective nutritional supports for patients with chronic obstructive pulmonary diseases (COPD) is still challenging. This study was conducted to investigate the efficacy of daily consumption of fortified whey on inflammation, muscle mass, functionality, and quality of life in patients with moderate-to-severe COPD. METHODS: A single-blind, randomized trial study was performed on patients with COPD (n = 46). Participants in the intervention group (n = 23) daily received 250 ml of whey beverage fortified with magnesium and vitamin C for 8 weeks. Any changes in inflammatory cytokines (including interleukin- 6 (IL-6) and tumor necrosis factor (TNFα)) were the primary outcomes and the secondary outcomes were fat-free mass, handgrip strength, malnutrition, glutathione and malondialdehyde serum concentrations, and health-related quality of life (HRQoL). Body composition and muscle strength were measured by Bioelectrical Impedance Analysis (BIA) and hydraulic hand dynamometer, respectively. Fat-free mass index (FFMI) was also calculated. RESULTS: At the end of the study, 44 patients were analyzed. There were significant decreases in IL-6 concentrations in the intervention group compared to the control group. Also, FFMI, body protein, and handgrip strength increased significantly in the intervention group with significant changes between two groups. Moreover, improvement in health-related quality of life was observed in the intervention group compared to the control group. There were no significant changes in other study variables. CONCLUSIONS: This novel nutritional intervention decreased inflammatory cytokines levels, improved indices of skeletal muscle mass and muscle strength, and ultimately, increased HRQoL in patients with moderate-to-severe COPD. Thus, it is suggested to do further studies to assess the effects of nutrition intervention on COPD progression. TRIAL REGISTRATION: IR.SUMS.REC.1396.85 ( https://www.irct.ir/ ).

Royal jelly does not improve markers of glycemia: A systematic review and meta-analysis of Randomized Clinical Trials.

Bee products including propolis, bee wax, pollen and royal jelly (RJ) have been used as medicine from ancient times. A vast number of in-vivo and in-vitro studies as well as clinical trials have been conducted to investigate potential health related properties of RJ. A growing number of clinical trials have been performed to assess effects of RJ ingestion on different metabolic markers including glycemia, with diverse results. In the current meataanalysis, we aimed to evaluate effects of RJ ingestion on glycemic markers compared with placebo and set directions for future research. Electronic databases including Scopus, Pubmed, Scholar, Cochrane, Proquest, SID and Magiran were searched and 5 eligible studies were included in the quantitative analysis. Review Manager Software was used for statistical analysis and random effects model was used for pooling data. A total of 205 participants for FPG and 130 participants for HbA1c were included. The overall analysis revealed that RJ consumption reduced FPG by 0.95 mg/dl (95% CI: -5.83 to 3.87; p = 0.69; I2 = 0%; Tau2 = 0.00) and HbA1c by 0.32 (95% CI: -0.87 to 0.23; p = 0.25; I2 = 69 %; Tau2 = 0.16) which were not statistically significant. Funnel plot demonstrated no publication bias. In conclusion, RJ supplementation did not beneficially affect markers of glycemia. However, due to methodology issues and potential confounders like diet as well as diverse populations, we recommend future studies well designed and well controlled for major confounders so we can update these data to more precise results and more accurate conclusion.

Effects of a therapeutic lifestyle change diet and supplementation with Q10 plus L-carnitine on quality of life in patients with myocardial infarction: A randomized clinical trial.

Introduction: Myocardial infarction (MI) has a deleterious effect on quality of life (QoL), which can affect cardiac prognosis after MI. Thus, new strategies have to be identified for improving the QoL. To our knowledge, no studies have been conducted on the impact of therapeutic lifestyle change (TLC) diet and L-carnitine plus Q10 supplementation on QoL after MI. Methods: The study aimed to measure 128 MI patients' QoL using MacNew QoL questionnaire (global scales and physical, emotional, and social subscales) before and 3 months after the intervention. The patients were divided into 4 groups. Group A received TLC diet, group B orally received Q10 150 mg/d and L-carnitine 1200 mg/d, and group C received a combination of carnitine plus Q10 and TLC diet. Finally, group D, as the control group, only underwent the routine care. Results: The results showed a significant increase in MacNew questionnaire's physical, emotional, and social subscales in the four groups after the intervention. The results of within-group analysis showed that the physical and emotional subscales changed significantly (P < 0.001 and P < 0.022, respectively). In the emotional subscale, TLC group showed a significant improvement compared to groups B and D (P < 0.019 and P < 0.001, respectively), but not group C (P < 0.681). In the physical subscale, Q10 plus L-carnitine group showed a significant improvement compared to groups A and D (P < 0.001 and P < 0.0001, respectively), but not group C (P < 0.860). In the global scale, combination of carnitine plus Q10 and TLC diet group demonstrated a considerable improvement compared to groups A, B, and D (P < 0.001, P < 0.001, and P < 0.001, respectively). Nevertheless, the results of within-group analysis revealed no significant differences among the four groups regarding the social subscale (P < 0.229). Conclusion: Both TLC diet and supplementation with Q10 and L- carnitine had a positive effect on the physical and emotional subscales of MacNew questionnaire and may improve post-MI prognosis. Based on the results, combination of Q10 plus L-carnitine and TLC die can be a potential intervention for improving QoL and secondary prevention.

Intradialytic Oral Protein Supplementation and Nutritional and Inflammation Outcomes in Hemodialysis: A Randomized Controlled Trial.

BACKGROUND: Malnutrition is a common finding in hemodialysis patients and can increase oxidative stress and inflammation levels. STUDY DESIGN: A randomized, controlled, nonblinded, parallel trial. SETTING & PARTICIPANTS: 92 hemodialysis patients from a single center with malnutrition according to subjective global assessment (SGA) score (SGA score > 7). INTERVENTION: 3 treatment groups (23 patients each) received 220mL of fermented vitamin E-fortified whey beverage (15g of whey protein concentrate + 600IU of vitamin E) or 220mL of fermented whey beverage (15g of whey protein concentrate) or vitamin E (600IU) 3 times a week for 8 weeks. The control group (23 patients) received no intervention. OUTCOME & MEASUREMENTS: Primary outcomes were change in SGA score and malnutrition-inflammation score (MIS) from baseline to the end of the trial. RESULTS: At the end of the study, 83 patients were analyzed (2, 3, 1, and 3 patients left the study in the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively). Changes in SGA scores were -3.48 (95% CI, -4.90 to -2.00), -3.22 (95% CI, -4.13 to -2.30), -1.70 (95% CI, -3.20 to -0.24), and 1.56 (95% CI, 0.60 to 2.50) for the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P<0.001; P≤0.001 for each treatment group vs control). Changes in MISs were -3.17 (95% CI, -4.40 to -1.90), -1.83 (95% CI, -2.50 to -1.10), -2.30 (95% CI, -3.50 to -1.10), and 1.48 (95% CI, 0.65 to 2.30) for the vitamin E-fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P<0.001; P<0.001 for each treatment group vs control). Few adverse effects were reported in any group. LIMITATIONS: Lack of blinding, small sample size, and short duration. CONCLUSIONS: Whey protein in the form of a new fermented whey beverage and vitamin E supplementation may improve SGA score and MIS in the short term.

Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial.

BACKGROUND: Insulin resistance is a measure of metabolic stress in the perioperative period. Before now, no clinical trial has determined the summative effects of glutamine, L-carnitine, and antioxidants as metabolic conditioning supplements in the perioperative period. OBJECTIVES: The purpose of this study was to determine the effects of a new conditioning supplement on perioperative metabolic stress and clinical outcomes in non-diabetic patients. PATIENTS AND METHODS: In this randomized controlled trial, 89 non-diabetic patients scheduled for coronary artery bypass grafting, with ejection fractions above 30%, were selected. Using the balanced block randomization method, the patients were allocated to one of four study arms: 1) SP (supplement/placebo): supplement seven days before and placebo 30 days after the surgery; 2) PS: placebo before and supplement after the surgery; 3) SS: supplement before and after the surgery; and 4) PP: placebo before and after the surgery. The supplement was composed of glutamine, L-carnitine, vitamin C, vitamin E, and selenium, which was manufactured for the first time by this research team. Five blood samples were drawn: seven days preoperatively, at the entrance to the operating room, while leaving the operating room, seven days postoperatively, and 30 days postoperatively. Levels of glucose, insulin, and HbA1c were measured in blood samples. Insulin resistance and sensitivity were calculated using a formula. Surgical complications were assessed 30 days postoperatively. Data analysis was done using one-way ANOVA, the Chi-square test, and a general linear model repeated-measures analysis with Bonferroni adjustment. RESULTS: Blood glucose levels were increased postoperatively in the four groups (< 0.001), but a significantly higher increase occurred in the PP group compared to the SP (0.027), PS (0.026), and SS (0.004) groups. The superficial wound infection rate was significantly different between the four groups (0.021): 26.08% in PP, 9.09% in SP, 4.54% in PS, and 0% in SS. CONCLUSIONS: Our new metabolic conditioning supplement, whether given pre- or postoperatively, led to better perioperative glycemic control and decreased postsurgical wound infections in non-diabetic patients.

The effect of calcitriol on lipid profile and oxidative stress in hyperlipidemic patients with type 2 diabetes mellitus.

BACKGROUND: Cardiovascular mortality is high among diabetic patients due to abnormalities in the plasma lipid and lipoprotein metabolism, and increased oxidative stress. This study aimed to investigate the effects of active vitamin D on serum lipids and oxidative stress markers in type 2 diabetic patients. METHODS: A double-blind randomized placebo-controlled trial was carried out in 70 participants with type 2 diabetes, aged 30-75 years of age. The participants were randomly assigned to two groups. One group received two capsules of calcitriol (0.25 µg 1,25-dihydroxycholecalciferol per capsule) per day. The second group received placebo tablets. All participants received their oral hypoglycemic drugs as prescribed by the endocrinologist. At the beginning, after 6 weeks, and at the end of the 12-week supplementation trial, serum total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), and serum malondialdehyde (MDA) levels were measured. RESULTS: There was a significant reduction in total cholesterol, LDL-cholesterol, TG, and MDA levels in both treatment and placebo groups (P < 0.05). Serum HDL-cholesterol level decreased significantly in the placebo group (P < 0.05), while it remained unchanged in the treatment group. However, the P values related to the between group's comparisons were not significant for any variables. CONCLUSION: Active vitamin D reduced lipid profile and oxidative stress markers in diabetic patients compared to the control group, but these alterations were not statistically significant.

Effects of "vitex agnus castus" extract and magnesium supplementation, alone and in combination, on osteogenic and angiogenic factors and fracture healing in women with long bone fracture.

BACKGROUND: The purpose of this study was to investigate the effects of the combination of vitex agnus castus extract, as a source of phytoestrogens, plus magnesium supplementation on osteogenic and angiogenic factors and callus formation in women with long bone fracture. MATERIAL AND METHODS: In a double-blind randomized placebo controlled trial, 64 women with long bone fracture, 20-45 years old, were randomly allocated to receive 1) one Agnugol tablet (4 mg dried fruit extract of vitex agnus castus) plus 250 mg magnesium oxide (VAC + Mg group (n = 10)), 2) one Agnugol tablet plus placebo (VAC group (n = 15)), 3) placebo plus 250 mg magnesium oxide (Mg group (n = 12)), or 4) placebo plus placebo (placebo group (n = 14)) per day for 8 weeks. At baseline and endpoint of the trial, serum alkaline phosphatase, osteocalcin, and vascular endothelial growth factor (VEGF) were measured together with radiological bone assessment. RESULTS: There were no significant differences in the characteristic aspects of concern between the four groups at baseline. Despite the increased level of alkaline phosphatase in the VAC group (188.33 ± 16.27 to 240.40 ± 21.49, P = 0.05), administration of VAC + Mg could not increase alkaline phosphatase activity. However, treatment with VAC + Mg significantly enhanced the osteocalcin level. The serum concentration of VEGF was increased in the VAC group (269.04 ± 116.63 to 640.03 ± 240.16, P < 0.05). Callus formation in the VAC + Mg group was higher than the other groups but the differences between the four groups were not significant (P = 0.39). No relevant side effect was observed in patients in each group. CONCLUSION: Our results suggest that administration of vitex agnus castus plus magnesium may promote fracture healing. However, more studies need to further explore the roles of vitex agnus castus in fracture repair processes.

The effect of conjugated linoleic acids and omega-3 fatty acids supplementation on lipid profile in atherosclerosis.

BACKGROUND: Cardiovascular diseases (CVD) are the most serious cause of mortality in developed and developing countries. Epidemiological studies indicated that dyslipidemia is the major risk factor of CVD. Dyslipidemia can be modified either by proper lifestyle or medical intervention or by the combination of both. Conjugated linoleic acids (CLA) and ω3 fatty acids have beneficial effects on plasma lipids and lipoproteins. The aim of this study was to evaluate the effect of CLA and omega-3 fatty acids (ω-3 fatty acids) supplementation on lipid profile in atherosclerosis patient. MATERIALS AND METHODS: This study was a 2-month clinical randomized trial. Ninety atherosclerotic patients with angiographically diagnosed coronary atherosclerosis who were referred to Emam Reza Heart Clinic of Shiraz University of Medical Sciences from February to march 2011 were selected if they fulfilled the inclusion criteria. The participants were randomly classified into 3 groups receiving 3 g/d CLA or 1 920 mg/d ω3 or placebo for 2 months. High-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), triglycerides (TG), and total cholesterol were measured before and after the intervention. This study was a two-month clinical randomized trial. RESULTS: Data were analyzed using SPSS software (SPSS Inc, Chicago, version19). Although CLA did not appear to have a significant effect on TG, ω3 supplementation significantly reduced TG level. Consumption of CLA and ω3 supplementation did not significantly affect HDL cholesterol, LDL cholesterol, and total cholesterol. CONCLUSIONS: ω3 supplementation significantly reduced TG level but CLA and ω3 did not show significant changes in other indices of lipid profile in atherosclerotic patients.

Serum IL-18 and hsCRP correlate with insulin resistance without effect of calcitriol treatment on type 2 diabetes.

BACKGROUND: Chronic low-grade systemic inflammation presented in Type 2 diabetes mellitus plays a major role in disease progression as well as development of micro- and macro-vascular complications of diabetes. Therefore, reducing inflammation can be beneficial in prevention of diabetes complications. OBJECTIVES: To investigate the association between insulin resistance and inflammatory markers, and assessing the effects of oral Calcitriol on inflammatory cytokines in type 2 diabetic patients. METHODS: In this double-blind randomized placebo-controlled trial, 70 participants with type-2 diabetes were randomly divided to two groups. One group received two capsules of Calcitriol (0.25 µg 1,25-dihydroxy cholecalciferol per each capsule) per day. The second group received placebo tablets. At the beginning of the study, we assessed insulin resistance and its relation to inflammatory profile. Serum high sensitive C-reactive protein (hs CRP), interleukin-6 and interleukin-18 were also measured at the beginning and the end of the 12-week supplementation trial. RESULTS: Mean calcium, phosphorus and vitamin D concentrations in the study participants were 8.98 ± 0.79 mg/dL, 3.86 ± 0.50 mg/dL and 40.91 ± 30.9 ng/mL, respectively. IL-18 and hsCRP had significant positive associations with insulin resistance markers and negative associations with insulin sensitivity markers. At the end of the 12-week supplementation trial, no significant difference was seen in serum levels of hsCRP, IL-6 and IL-18 between the two groups, while these values were adjusted for baseline values. CONCLUSION: Inflammation was associated with insulin resistance in diabetic patients. No anti-inflammatory effect of Calcitriol in terms of decreasing hsCRP, IL-6 and IL-18 detected.

Relation between Body Iron Status and Cardiovascular Risk Factors in Patients with Cardiovascular Disease.

BACKGROUND: There is conflicting evidence regarding the relationship between iron stores and cardiovascular disease (CVD). The present study aimed to investigate the association between body iron indices and some cardiovascular risk factors. METHODS: In a case-control study conducted in the south of Shiraz, Iran, we determined ferritin, iron, total iron binding capacity (TIBC), metabolic risk factors, C-reactive protein (CRP), and anthropometric measurements in 100 men aged 45 years and higher with newly diagnosed CVD and 100 adjusted controls without evidence for CVD. RESULTS: The mean of low density lipoprotein (LDL-c), CRP, and ferritin concentrations were significantly higher in cases than controls, and high density lipoprotein (HDL-c) was significantly lower in cases than controls. Pearson correlation coefficient between CRP and the other risk factors in case group showed that only ferritin, serum iron, waist circumference, and LDL-c significantly correlated with CRP (r = 0.32 with P < 0.001, r = 0.29 with P < 0.05, r = 0.41 with P < 0.01, and r = 0.36 with P < 0.001, respectively). CONCLUSIONS: This study indicated an association between a positive balance of body iron and CVD. Hence, caution should be exercised in administration of iron supplements to patients with CVD and in consumption of food rich in iron by them.

Impact of treatment with oral calcitriol on glucose indices in type 2 diabetes mellitus patients.

INTRODUCTION: Type 2 diabetes is a major public health problem. Recent epidemiological evidence also points to a potential association of vitamin D insufficiency with adverse metabolic risks, including that for type 2 diabetes. SUBJECTS AND METHOD: A double-blind randomized placebo-controlled trial was carried out. Seventy subjects with type 2 diabetes, age 30-75 years old, were randomly assigned in a double-blind fashion to two groups. One group received two capsules of calcitriol (0.25 µg 1,25-dihydroxy cholecalciferol per each capsule) per day. The second group received placebo tablets. At the beginning, middle and the end of the 12 week supplementation trial, serum glucose, insulin, calcium and phosphorous, HbA1c and 25(OH) vitamin D were measured. RESULTS: There was no significant difference between two groups at baseline. At the end of the study, fasting plasma glucose increased in the control group (p=0.038), while it remained unchanged in calcitriol group. Level of insulin and HbA1c increased significantly in both groups (p=0.013 and 0.0004 in treatment and control group). Regarding insulin resistance indices, there was a significant change in HOMA-IR and QUICKI in both groups (p=0.023 and 0.002 in treatment and 0.001 and <0.001 in control group respectively). Insulin secretion as assessed by HOMA-%ß, remained relatively unchanged in the control group, while it increased significantly in the treatment group at the end of study (p=0.009). CONCLUSION: Vitamin D supplementation attenuated the increase in glycemia, and increased insulin secretion, but had no effect on insulin resistance.

Effect of iron repletion and correction of iron deficiency on thyroid function in iron-deficient Iranian adolescent girls.

The aim of this study was to determine whether iron supplementation in iron-deficient adolescent girls would improve thyroid function. A double-blind clinical trial was performed in a region in southern I.R. Iran. A total of 103 iron deficient participants were chosen. In all, 94 participants successfully completed this study. Participants were randomly assigned to one of two groups and treated with a 300 mg ferrous sulfate 5 times/week (n = 47) and placebo 5 times/week (n = 47) for 12 weeks. Blood samples were collected and assayed for hemoglobin, hematocrit, serum ferritin, iron, total iron binding capacity (TIBC), Thyroid stimulating hormone (TSH), total thyroxine (TT4), total triiodothyronine (TT3), free thyroid hormones (FT4 and FT3), triiodothyronine resin uptake (T3RU), reverse triiodothyronine (rT3), selenium and albumin concentrations. Statistical analysis was performed with parametric and non-parametric methods as appropriate. Data analysis revealed a significant increase in TT4, TT3, T3RU and a significant decrease in rT3 concentration in comparison to initial values in iron treated group (12%, p<0.001; 3.5%, p<0.001; 16%, p<0.05 and 47%, p<0.001, respectively). At 12 week there were significant differences between control and placebo in TT4, TT3, T3RU and rT3 concentrations (9.9 vs 8.4 microg dL(-1), 145.2 vs 130.4 microg dL(-1), 32.5 vs 28.4% and 23 vs 41 microg dL(-1), respectively, all p<0.001). Alterations in FT3 and TSH concentration were not significant, but concentration of FT4 revealed a significant difference between the beginning and the end of the study in iron treated group (10.3 vs 11.4, p<0.001). Iron supplementation improves some indices of thyroid function in iron-deficient adolescent girls.