The effects of vitamin D supplementation on interictal serum levels of calcitonin gene-related peptide (CGRP) in episodic migraine patients: post hoc analysis of a randomized double-blind placebo-controlled trial.

BACKGROUND: Emerging evidence showed promising effects of vitamin D on headaches characteristics. Thus, it seems there is still a need for more researches to clarify the mechanisms by which this vitamin exerts anti-migraine effects. METHODS: The present study was conducted as a 16-week randomized double-blind placebo-controlled trial on 80 episodic migraine patients allocated in 2 parallel groups each consisted of 40 patients who received vitamin D 2000 IU/d or placebo. At baseline and after the intervention completion, headache diaries and migraine disability assessment questionnaire (MIDAS) were used to assess migraine related variables in patients. Also, interictal serum concentration of calcitonin gene-related peptide (CGRP) (as the dominant mediator of migraine pain pathogenesis) was evaluated using ELISA method. RESULTS: The mean (SD) of age in the vitamin D and placebo groups was 37 (8) and 38 (12) years, respectively. ANCOVA test adjusted for baseline values, and confounders showed vitamin D supplementation resulted in a significant improvement in MIDAS score after 12 weeks in the intervention group (21.49 (16.22-26.77)) compared to placebo (31.16 (25.51-36.82) P value: 0.016). Moreover, after controlling for baseline levels, and other variables using ANCOVA, CGRP level was appeared to be significantly lower following vitamin D supplementation (153.26 (133.03-173.49) ng/L) than the patients in the placebo arm (188.35 (167.15-209.54) ng/L) (P value = 0.022). CONCLUSION: According to the current findings, vitamin D supplementation in episodic migraineurs, particularly in those with migraine with aura, may potentially improve migraine headache characteristics and disability probably through attenuating CGRP levels. Therefore, these results could provide a new insight into anti-nociceptive effects of vitamin D; however, more studies are required to confirm our findings. TRIAL REGISTRATION: The trial is registered in the Iranian registry of clinical trials (IRCT) at 11 July 2018, with IRCT code: IRCT20151128025267N6.

Vitamin D3 might improve headache characteristics and protect against inflammation in migraine: a randomized clinical trial.

INTRODUCTION: Due to anti-inflammatory effects of vitamin D3, we aimed to explore the effects of supplementation with this vitamin on headache characteristics and serum levels of pro/anti-inflammatory markers in migraineurs. METHODS AND MATERIALS: This placebo-controlled, double-blind study included 80 episodic migraineurs who randomly assigned into two equal groups to receive either daily dose of vitamin D3 2000 IU (50 µg) or placebo for 12 weeks. At baseline and after the trial, headache characteristics were determined using diaries and serum levels of interleukin (IL)-10, IL-6, inducible nitric oxide synthase (iNOS), and cyclooxygenase-2 (Cox-2) were assessed via ELISA method. RESULTS: At the end of trial, analysis of covariance (ANCOVA) adjusted for baseline values, and confounders revealed that vitamin D3 supplemented group experienced significantly lower headache days per month (4.71), reduced attacks duration (12.99 h/attack), less severe headaches (5.47, visual analog scale), and lower analgesics use/month (2.85) than placebo group (6.43, 18.32, 6.38 and 4.87, respectively) (P values < 0.05). Using ANCOVA adjusted for baseline levels and confounding variables, it was found that serum levels of IL-10 and Cox-2 did not significantly differ between groups after the experiment; whereas, iNOS serum level was significantly reduced in the intervention group (106.06 U/L) comparing to the controls (156.18 U/L P : 0.001). Also, the patients receiving vitamin D3 yielded a marginally significant lower IL-6 serum concentration (76.43 ng/L) compared to placebo (93.10 ng/L) (P value:0.055). CONCLUSION: Based on the results of this study, we found that 2000 IU (50 µg)/day vitamin D3 supplementation for 12 weeks could improve headache characteristics and might reduce neuro-inflammation in episodic migraine.

Retinyl Palmitate Supplementation Modulates T-bet and Interferon Gamma Gene Expression in Multiple Sclerosis Patients.

Vitamin A derivatives such as retinoic acid may improve the impaired balance of CD4+ T cells in autoimmune and inflammatory diseases. This study is a double-blind randomized trial to evaluate the effect of vitamin A (as form of retinyl palmitate) supplementation on multiple sclerosis (MS) patients. Thirty-nine patients were enrolled and randomly assigned to two groups. Both groups were followed for 6 months. The experimental group received 25,000 IU of retinyl palmitate daily, while the control group received a placebo. Before and after the study, the expression of interferon gamma (IFN-γ) and T-bet genes was evaluated in peripheral blood mononuclear cells of patients by RT-PCR. The results showed that after 6 months of supplementation, expression of IFN-γ and T-bet was significantly decreased. These data suggest that retinyl palmitate supplementation can modulate the impaired balance of Th1 and Th2 cells and vitamin A products that may be involved in the therapeutic mechanism of vitamin A in MS patients. This study provides information regarding the decreased gene expression of IFN-γ and T-bet in MS by retinyl palmitate supplementation.

ω-3 fatty acid differentially modulated serum levels of IGF1 and IGFBP3 in men with CVD: a randomized, double-blind placebo-controlled study.

OBJECTIVE: Studies have reported elevated serum insulin-like growth factor (IGF)-1 levels followed by ω-3 supplementation in various groups. Considering decreased level of IGF1 in patients with cardiovascular disease (CVD) and protective effects of IGF1 against CVD progression and myocardial infarctions mortality, this study was performed with the aim of determining effects of ω-3 supplementation on serum levels and gene expression of IGF1 and IGF binding protein-3 (IGFBP3) in men with CVD. METHODS: Sixty-two middle-aged (55.9 ± 6.5 y) non-obese men with CVD followed the study protocol in two groups of ω-3 (n = 31) or placebo (n = 31) supplementation. Participants took ω-3 supplement or placebo (edible paraffin) for 8 wk and were asked not to change their diet or physical activity plan. Anthropometric and lipid profile characteristics, serum IGF1, serum IGFBP3 and also IGF1 and IGFBP3 gene expression in peripheral blood mononuclear cells (PBMCs) were measured in all participants before and after the intervention. Statistical analyses were performed using SPSS software. RESULTS: There were no significant differences between the two study groups in age and body mass index at baseline. The groups also had no difference in baseline serum low-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, triacylglycerols, and IGF1. Compared with placebo, ω-3 supplementation increased serum IGF1 levels (P = 0.01), and decreased serum level of IGFBP3 (P = 0.02). There was a trending toward an increase in IGF1 expression and nonsignificant decrease in IGFBP3 expression. CONCLUSIONS: ω-3 supplementation in patients with CVD increases serum IGF1 levels and decreases serum IGFBP3. Further research is warranted to investigate the underlying mechanisms.

Association of nesfatin-1 level with body composition, dietary intake and resting metabolic rate in obese and morbid obese subjects.

AIMS: Nesfatin-1 identified neuroendocrine peptide is involved in regulation of homeostasis via modulation of metabolism, energy homeostasis and food intake. We aimed to investigate the associations of circulating nesfatin-1 level with food intake, body composition and resting metabolic rate (RMR) and also examine the correlation between circulating peroxisome proliferator-activated receptor gamma (PPARγ) and nesfatin-1 levels in obese and morbid obese subjects. METHODS: A total of 96 obese subjects (including 18 morbid obese subjects) were participated in the current cross-sectional study. We assessed the body composition with the use of Body Composition Analyzer. RMR was measured by means of the MetaCheck™, an instrument designed to measure RMR using indirect calorimetry. All baseline blood samples were obtained following an overnight fasting. Plasma concentrations of nesfatin-1 and circulating PPARγ were measured with the use of an ELISA method. Statistical analyses were performed using SPSS. RESULTS: We found significant associations between fat percent and circulating nesfatin-1 in obese and morbid obese subjects. There was main association between circulating nesfatin-1 and PPARγ concentration in obese subjects and it was more strong association in morbid obese participants. There was marginally significant differences between percent predicted RMR between different categorized nesfatin-1 levels. There were also higher intakes of calorie, carbohydrate and protein in obese group who had lower concentration of nesfatin-1. CONCLUSIONS: Our data indicated the fat percent as main determinant factor in circulating nesfatin-1 level. It appears nesfatin-1 and PPARγ might be concurrently involved in adipogenesis pathway.

Relationship between blood donors' iron status and their age, body mass index and donation frequency.

CONTEXT AND OBJECTIVE: Regular blood donation may decrease body iron storage and lead to anemia. The aim here was to evaluate the iron status of Iranian male blood donors and the impact of age, body mass index (BMI) and donation frequency over one year, on iron status indices. DESIGN AND SETTING: Cross-sectional, descriptive and analytical study at Tehran Blood Transfusion Center, Tehran, Iran. METHODS: Between July and September 2011, 117 male blood donors were selected and divided into four groups according to their frequency of blood donation. Thirty male non-donors were also recruited as controls after adjusting for age, weight, height, smoking habits and monthly income. Iron status indices and some criteria such as general health and dietary measurements were determined among all subjects. RESULTS: The values of the iron-related parameters were significantly lower among donors than among non-donors. Only total iron binding capacity (TIBC) was found to be significantly higher among different donor groups than in the controls. A significant positive correlation was observed between age and serum ferritin (SF) only among the donors who had donated once within the preceding year. The iron status indices did not show any significant relationship with BMI among donors or non-donors. CONCLUSION: A donation frequency of more than twice a year had a significant influence on iron-related parameters. Therefore, without annual measurement of these parameters, further phlebotomies may lead to iron deficiency and donor rejection in the future.

Eicosapentaenoic acid improves insulin sensitivity and blood sugar in overweight type 2 diabetes mellitus patients: a double-blind randomised clinical trial.

INTRODUCTION: Diabetes mellitus is the most common metabolic disorder in humans, and its incidence is increasing rapidly worldwide. Although polyunsaturated fatty acids have beneficial effects on diabetes mellitus, previous data regarding the possible positive effects of n-3 fatty acids on glycaemic indices were inconclusive. We conducted a double-blind randomised clinical trial to determine the effects of eicosapentaenoic acid (EPA), an n-3 polyunsaturated fatty acid, on overweight patients with type 2 diabetes mellitus (T2DM). METHODS: This double-blind, placebo-controlled randomised clinical trial was conducted on a total of 67 overweight patients with T2DM for a duration of three months. Of these 67 patients, 32 received 2 g purified EPA daily, while 35 received a placebo of 2 g corn oil daily. The patients' fasting plasma glucose (FPG), serum insulin, glycated haemoglobin (HbA1c) and insulin sensitivity indices were assessed. RESULTS: After three months of EPA supplementation, the group that received EPA showed significant decreases in FPG (p < 0.001), HbA1c (p = 0.01) and homeostasis model assessment of insulin resistance (HOMA-IR) (p = 0.032), when compared to the placebo group. EPA supplementation resulted in decreased serum insulin levels, with the levels between the EPA and placebo groups showing a significant difference (p = 0.004). CONCLUSION: The results of our study indicate that EPA supplementation could improve insulin sensitivity. It was able to decrease serum insulin, FPG, HbA1c and HOMA-IR. EPA could have beneficial effects on glycaemic indices in patients with T2DM.

Relationship between blood donors' iron status and their age, body mass index and donation frequency / Relacao entre os niveis de ferro de doares de sangue e idade, indice de massa corporal e frequencia de doacao

CONTEXT AND OBJECTIVE: Regular blood donation may decrease body iron storage and lead to anemia. The aim here was to evaluate the iron status of Iranian male blood donors and the impact of age, body mass index (BMI) and donation frequency over one year, on iron status indices. DESIGN AND SETTING: Cross-sectional, descriptive and analytical study at Tehran Blood Transfusion Center, Tehran, Iran. METHODS: Between July and September 2011, 117 male blood donors were selected and divided into four groups according to their frequency of blood donation. Thirty male non-donors were also recruited as controls after adjusting for age, weight, height, smoking habits and monthly income. Iron status indices and some criteria such as general health and dietary measurements were determined among all subjects. RESULTS: The values of the iron-related parameters were significantly lower among donors than among non-donors. Only total iron binding capacity (TIBC) was found to be significantly higher among different donor groups than in the controls. A significant positive correlation was observed between age and serum ferritin (SF) only among the donors who had donated once within the preceding year. The iron status indices did not show any significant relationship with BMI among donors or non-donors. CONCLUSION: A donation frequency of more than twice a year had a significant influence on iron-related parameters. Therefore, without annual measurement of these parameters, further phlebotomies may lead to iron deficiency and donor rejection in the future. .

CONTEXTO E OBJETIVO: Doação de sangue regular pode diminuir o armazenamento de ferro no organismo, conduzindo à anemia. O objetivo foi avaliar o estado de ferro de iranianos doadores de sangue do sexo masculino e o impacto da idade, índice de massa corporal (IMC) e frequência da doação ao longo de um ano sobre os índices do estado de ferro. TIPO DE ESTUDO E LOCAL: Estudo transversal, descritivo e analítico no Centro de Transfusão de Sangue de Teerã. MÉTODOS: Entre julho e setembro de 2011, foram selecionados 117 homens doadores de sangue, divididos em quatro grupos de acordo com a frequência de doação. Trinta homens não doadores foram também recrutados como controles, após ajustes para idade, peso, altura, tabagismo e renda mensal. Índices do estado de ferro, bem como alguns critérios como a saúde geral e medidas dietéticas, foram determinados entre todos os indivíduos. RESULTADOS: Os valores dos parâmetros relacionados ao ferro foram significativamente mais baixos entre os doadores em comparação aos não doadores. Somente capacidade de ligação de ferro total foi significativamente maior entre os diferentes grupos de doadores em comparação com os controles. Correlação positiva significante entre idade e ferretina sérica foi observada somente nos que tinham doado uma vez no ano anterior. Os índices do estado do ferro não mostraram relação significativa com o IMC entre doadores e não doadores. CONCLUSÃO: A frequência de doação de mais de duas vezes por ano teve influência significativa nos parâmetros relacionados ao ferro. Assim, sem medidas anuais desses parâmetros, flebotomias adicionais podem levar a deficiência de ferro e rejeição de doadores no futuro. .