Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in patients with cystic fibrosis: the study protocol for a randomized controlled trial.

BACKGROUND: Cystic fibrosis is an inherited disease, which is caused by the CFTR protein defects due to mutations in the CFTR gene. Along with CFTR dysfunction, exocrine pancreatic insufficiency plays a key role in persistent fat malabsorption in CF patients; therefore, deficiency of fat-soluble vitamins (A, D, E, and K) is still a therapeutic challenge. Even with efficient pancreatic enzyme medication and CF-specific vitamins, many patients with CF have fat-soluble vitamins deficiency. The present study aims to evaluate the efficiency of nanomicelle formulation of fat-soluble vitamins in children with CF in order to achieve the appropriate serum levels of these vitamins. METHODS: This prospective, single-blind control trial will be conducted at the Akbar Children's Hospital in Mashhad, Iran. Patients with CF will be enrolled based on the eligibility criteria. The control group will receive the standard formulation of fat-soluble vitamins similar to the routine CF treatment, and for the intervention group, the nanomicelle formulation of fat-soluble vitamins will be administered for 3 months. The primary outcome of this study is the measurement of serum levels of fat-soluble vitamins. The secondary outcomes are clinical assessment by the Shwachman-Kulczycki score, anthropometrics, and quality of life. Outcomes will be assessed before and after 3 months. DISCUSSION: Due to persistent fat-soluble vitamin deficiency in CF disease, the nanomicelle formulation could be proposed as a new delivery method of fat-soluble vitamins in the treatment of cystic fibrosis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20220415054541N1. Registered on July 23, 2022.

Impact of pomegranate juice on blood pressure: A systematic review and meta-analysis.

Despite the importance of polyphenol-rich fruits in decreasing cardiovascular mortality, the impact of pomegranate juice (PJ) on blood pressure is still unclear. To determine the effect of PJ on blood pressure. PubMed, Scopus, ISI Web of Science, and Cochrane Library were searched comprehensively using relevant keywords. All studies using pomegranate juice alone were included although limited to human studies and the English language. A random-effects model and the generic inverse variance approach were used to determine quantitative data synthesis. Meta-analysis of 14 clinical trials (n = 573 individuals) demonstrated a reduction in systolic BP (SBP) with pomegranate juice (MD: -5.02 mmHg, 95% CI: -7.55 to -2.48, p < 0.001). Effect of study duration showed pomegranate juice intake ≤2 months significantly decreased SBP (MD: -4.59 mmHg, 95% CI: -7.10 to -2.08, p < 0.001) and DBP (MD: -2.94 mmHg, 95% CI: -5.25 to -0.63, p = 0.01). Consumption of ≤300 mL pomegranate juice daily reduced SBP (MD: -6.11 mmHg, 95% CI: -9.22 to -3.00, p < 0.001). Counterintuitively, >300 mL/day of pomegranate juice showed no effect on SBP (MD: -3.28 mmHg, 95% CI: -6.85 to 0.27, p = 0.07) but a significant DBP reduction occurred (MD: -3.10 mmHg, 95% CI: -5.74 to -0.47, p = 0.02). Meta-regression showed that the SBP-lowering effect of pomegranate juice was associated with the dose of supplementation (p < 0.001). Pomegranate juice appeared to decrease SBP and DBP in a dose-dependent manner, but the benefit was lost after 2 months of pomegranate juice intake.

Comprehensive assessment of nutritional status and nutritional-related complications in newly diagnosed esophageal cancer patients: A cross-sectional study.

BACKGROUND & AIMS: Malnutrition is prevalent in upper gastrointestinal cancer patients. The purpose of this study was a comprehensive assessment of nutritional status in newly diagnosed patients with esophageal cancer. METHODS: Newly diagnosed esophageal cancer patients were referred to a chemo-radiation referral center in Mashhad, Iran, between February 2017 to February 2019. Anthropometric indices, a Patient-Generated Subjective Global Assessment (PG-SGA) tool, body composition, dietary intake, nutritional-related complications, and laboratory tests were assessed. RESULTS: One hundred and eighty-nine patients with a mean age of 67.1 ± 12 and a male to female ratio of 98 to 91 were included. Ninety-seven (51.3%) of patients had experienced significant weight loss and 56 (29.6%) were underweight at diagnosis. According to PG-SGA, 179 (94.7%) needed nutritional interventions. Reduced muscle mass and low handgrip strength were observed in 70 (39.4%) and 26 (14.4%) of patients, respectively. Inadequate intakes of energy (less than 24 kcal/kg/day) and protein (less than 1.2 g/kg/day) were found in 146 (77.8%) and 171 (91%) patients, respectively. The mean total daily energy and protein intakes of subjects were 943.8 ± 540 kcal/day, and 30.6 ± 21 g/day, respectively. The most common nutritional-related complications were as follows: dysphagia (84.8%), anorexia (31.6%), constipation (62.1%), esophageal pain (48.4%), and dyspepsia (41.1%). CONCLUSION: Our study demonstrated a high prevalence of malnutrition in newly diagnosed esophageal cancer patients. This fact demonstrates the importance of early screening of nutritional status via PG-SGA tool, clinical evaluation, dietary intake evaluations, and laboratory tests, based on which effective nutritional interventions and Symptoms management may be introduced in these patients.

Association of vitamin D status with liver and kidney disease: A systematic review of clinical trials, and cross-sectional and cohort studies.

Background: Vitamin D deficiency (VDD) is a major public health problem. There are few comprehensive systematic reviews about the relationship between Vitamin D status and liver and renal disease in Iran. Methods: We systemically searched the following databases: Web of Science; PubMed; Cochrane Library; Scopus; Science Direct; Google Scholar and two Iranian databases (Scientific Information Database (SID) and IranMedex) up until November 2017 to identify all randomized control trials (RCTs), case control, cross-sectional and cohort studies investigating the association between vitamin D and any form of liver or kidney disease. Results: Vitamin D insufficiency, or deficiency (VDD), is highly prevalent in Iran, reports varying between 44.4% in Isfahan to 98% in Gorgan. There is also a high prevalence of VDD among patients with liver or kidney disease, and the administration of vitamin D supplements may have beneficial effects on lipid profile, blood glucose, liver function and fatty liver disease, and bone health. Low serum vitamin D levels are related with abnormalities in these laboratory and clinical parameters. Conclusion: VDD is prevalent in patients with chronic liver or renal disease in Iran. There appear to be several beneficial effects of vitamin D supplementation in vitamin D deficient patients with liver or kidney disease.

The effect of vitamin D fortified products on anthropometric indices: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: The reported effects of vitamin D on anthropometric indices have been inconsistent. This meta-analysis was conducted in order to assess the impact of vitamin D fortified food on weight, body mass index (BMI), fat mass, waist circumference (WC), hip circumference (HC) and waist to hip ratio (WHR). MATERIALS AND METHODS: PubMed/Medline, ISI Web of Knowledge, ScienceDirect, Scopus, Cochrane Library and Google Scholar were searched up to the end of 2019. We selected only randomized controlled trials in which vitamin D fortified food was used as the intervention, and a regular diet was used in the control group. RESULTS: Vitamin D fortified products appeared to have a significant effect on WC (MD: -1.283; 95% CI,-1.892 to -0.674) and WHR (MD: -0.020; 95%CI: -0.035 to -0.004). CONCLUSION: This meta-an-alysis showed that whilst a diet containing vitamin D fortified foods does not reduce body weight or BMI, it has beneficial effect on WHR and WC.

A systematic review and meta-analysis of the effect of Vitamin D-fortified food on glycemic indices.

Some reports indicated that Vitamin D may improve glycaemia indices in diabetic patients. The aim of this systematic and meta-analysis was to evaluate effects of Vitamin D fortification on indices of glycemic control. Six databases (PubMed/Medline, ISI Web of Knowledge, Cochrane Library, Science Direct, Scopus, and Google Scholar) were searched, for randomized controlled trials that were published up to September 2018 and that compared the effect of Vitamin D-fortified food versus regular diet in relation to glycemic control. Of the 4,379 studies originally found, 11 articles remained to be assessed for meta-analysis. Vitamin D fortification was associated with a significant improvement in fasting serum glucose (mean difference [MD]: -2.772; 95% confidence interval [CI]: -5.435 to -0.109) and fasting serum insulin (MD: -2.937; 95% CI: -4.695 to -1.178) in patients with Type 2 diabetes mellitus. A diet with food enriched with Vitamin D was associated with a significant improvement in homeostatic model assessment of insulin resistance (MD: -1.608; 95% CI: -3.138 to -0.079) but was not associated with a significant reduction in hemoglobin A1C (MD: 0.034; 95% CI: -0.655 to 0.069). This meta-analysis indicates that Vitamin D fortification improves indices of glycemic control. Hence, food fortified with Vitamin D may be of potential therapeutic value in diabetic patients, as an adjuvant therapy.

The effects of vitamin D supplementation on indices of glycemic control in Iranian diabetics: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: This systematic review and meta-analysis aimed to assess the effects of vitamin D supplements on indices of glycemic control [homeostatic model assessment-insulin resistance (HOMA-IR), hemoglobin A1C (HbA1C), fasting blood glucose (FBG), and quantitative insulin-sensitivity check index (QUICKI) and lipid profile in diabetic patients. METHODS: Eight databases were searched, for randomized controlled trials (RCTs) or cross-sectional and cohort studies that have been published up to December 2017. We used the comprehensive meta-analysis (CMA) software for all statistical analysis and used the I2 index for assessing heterogeneity. A p value of <0.05 was considered as statistically significant. RESULTS: We found 621 articles, and after the exclusion of ineligible publications, 82 studies remained to be assessed of which 37 were used for meta-analysis. Vitamin D supplementation was associated with a significant improvement in FBG (p = 0.001 and 95% CI: -0.526 to -0.136) and HbA1C (p = 0.003 and 95% CI: 1.719 to -0.361) in individuals with type 2 diabetes mellitus (T2DM); while in women with gestational diabetes mellitus (GDM) the reduction in FBG (p = 0.071 and 95% CI: -0.873 to -0.035) and HbA1C (p = 0.199 and 95% CI: 3.270 to 0.681) failed to reach statistical significance. Treatment with vitamin D supplements was associated with an improvement in HOMA-IR in pregnant diabetic women (p = 0.028 and 95% CI: 0.924 to -0.053) and for individuals with diabetes mellitus (p = 0.005 and 95% CI: 1.772 to -0.319). The pooled result of the cross-sectional meta-analysis indicated that serum vitamin D concentrations were significantly lower in diabetic patients than in healthy controls (p = 0.018 and 95% CI: 0.587 to -0.054). CONCLUSION: This meta-analysis suggests that vitamin D supplementation improves indices of glycemic control (FBG, HOMA-IR, and HbA1C) in patients with diabetes mellitus. Hence, vitamin D supplements may be of potential therapeutic value in diabetic patients, as an adjuvant therapy along with other treatments.

Evaluation of the serum prooxidant-antioxidant balance before and after vitamin D supplementation in adolescent Iranian girls.

PURPOSE: Oxidative stress is caused by an imbalance between the antioxidant defenses and pro-oxidant production in favor of pro-oxidant production. Vitamin D has the potential for both pro- and anti-oxidative effects. The aim of this study was to assess the effect of high dose vitamin D supplementation on the prooxidant-antioxidant balance (PAB) in Iranian girls attending High School. MATERIALS AND METHODS: A total of 464 girls aged 12-18 years were asked to take vitamin D capsules containing 50000IU vitamin D3 once a week for a period of 9 weeks. All variables were determined at baseline and after 9 weeks of intervention. Fasting blood samples were taken from all subjects. The serum levels of 25OHD were measured using an electrochemiluminescence method. Serum PAB levels were determined using an ELISA reader at a wavelength of 450 nm. RESULTS: Vitamin D supplementation was associated with an increase in serum PAB (P < 0.001) and a reduction in serum LDL-C (P < 0.001), total cholesterol (P < 0.001) and HDL-C (P < 0.01) serum levels in Iranian adolescent girls. The results obtained from the current study show that there were significant improvements in weight (P < 0.001), BMI (P < 0.001) and FBG (P = 0.02) in adolescent girls who had 50-74.9 nmol/L serum 25OHD levels compared to <50 nmol/L ones after the vitamin D supplementation. There was no significant association between the serum PAB and all biochemical factors (P > 0.05 for all variables). CONCLUSIONS: The results showed that vitamin D supplementation has increased the PAB levels in teenage girls.

The effects of photodynamic and low-level laser therapy for treatment of oral lichen planus-A systematic review and meta-analysis.

BACKGROUND: Oral lichen planus (OLP) is a chronic immune-mediated disorder that inflicts oral mucosa in 0.5-2% of the population. Surgery, photodynamic therapy, laser therapy and most commonly pharmacological therapy (like corticosteroids) has been used for treating OLP. New phototherapy approaches have been shown to have positive effects on treating some oral lesions and the aim of our study was to assess the effects of different phototherapy treatments on OLP. METHODS: We conducted a comprehensive electronic search using the determined search strategy in MEDLINE, EMBASE and CENTRAL electronic databases. A hand search of the reference list of the relevant studies and related systematic reviews was also performed. RESULTS: For low-level laser therapy, before and after studies showed a significant difference in pain (MD = -4.39, CI = 95% -4.83, -3.96) and sign score (MD = -1.86, CI = 95% -2.53, -1.19) after treatment. The comparison between corticosteroid therapy and LLLT also showed a significant difference in their effects for severity (MD = 0.57, CI = 95% 0.04, 1.09), but no differences in sign (MD = 0.21, CI = 95% -0.83, 1.24)and pain (MD = -0.10, CI = 95% -0.57,0.38) score was found between these two methods. Before and after studies of photodynamic therapy did not reveal any differences in lesion size. (MD = -1.95, CI = 95% -4.39, 0.490). CONCLUSION: Low-level laser therapy seems to be a reliable alternative to corticosteroids for treating OLP without the adverse effects associated with the pharmacological method. No conclusive evidence for the effectiveness of photodynamic therapy in treating OLP lesion exists.