High-dose vitamin D supplementation is related to an improvement in serum alkaline phosphatase in COVID-19 patients; a randomized double-blinded clinical trial.

BACKGROUND: The benefits and harms of vitamin D supplementation in the treatment of COVID-19 have not yet been fully documented. In this study, we aimed to evaluate the effects of high-dose vitamin D supplementation on liver function tests in COVID-19. METHOD: This double-blinded randomized clinical trial was conducted on 140 hospitalized patients aged > 30 years. Patients were randomly allocated to receive either intervention group (n = 70 receiving 50,000 IU of vitamin D capsules orally as a single dose and then 10,000 IU syrup daily from the second day of admission for 30 days) and the control group (n = 70 receiving 1000 IU vitamin D syrup orally per day). Liver function tests (LFT), including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and Lactate Dehydrogenase (LDH) were evaluated at baseline and at the end of the intervention. Decision tree analysis was performed to identify the predictors for change in liver enzymes. RESULTS: Among COVID-19 patients, a significant decrease was observed in serum level of ALP between intervention and placebo groups (p = 0.04). In addition, decision tree analysis revealed that GGT, temperature, serum magnesium level at baseline and gender were the most important predictors of ALT changes in COVID-19 patients. CONCLUSION: High-dose vitamin D supplementation improved ALP markers among COVID-19 patients. More randomized controlled trials with longer follow-up times will be required.

A Mixed Model Approach for Estimating the Optimal Food Fortification of Vitamin D: Experiment Based on Mashhad Cohort Study in Iran.

BACKGROUND: Vitamin D deficiency is a prevalent problem in worldwide healthcare related to several system disorders. Food fortification as a solution is associated with several challenges including insufficient coverage of the entire population, required degree of fortification, the vehicles used for fortification and potential toxicity. This study aimed to determine the optimal amount of vitamin D for fortification without surpassing the upper intake level (UL) of intake at the 95th percentile of the Iranian population and compare two methods of food fortification. METHODS: This study is aimed to develop a model of two different fortifying approaches related to an available dataset called MASHAD cohort study. The dataset comprised demographic and nutritional data of 9704 Iranian individuals living in the Greater Mashhad region. The first approach was a computational method necessary to implement a range of eight foods and calculate the optimal approach. In the second case, we used the European formula method called ILSI. RESULTS: To find the appropriate value for fortification, we calculated the consumption of 400 IU and 1000 IU supplements of vitamin D. Three micrograms per 100 g in each food was the optimal output. We also used Flynn and Rasmussen's formula on our data. Using these methods, we found that 2.1 micrograms per 100 kcal provides the best result. Hence, using the two different approaches, the results appear to be consistent and promising. CONCLUSION: One interesting finding was that supplement consumption did not greatly affect the impact of fortification. This observation may support the hypothesis to determine the amount of fortification, and we can ignore the study population's supplement consumption.

Efficacy of low-fat milk and yogurt fortified with vitamin D3 on systemic inflammation in adults with abdominal obesity.

BACKGROUND: The prevalence of vitamin D deficiency is increasing globally and is associated with an increased risk of metabolic syndrome, autoimmune disease, and cardiovascular disease. Vit D deficiency is also associated with increased systemic inflammation. The current study aimed to determine the efficacy of low-fat milk and yogurt fortified with 1500 IU nano-encapsulated vitamin D, on systemic inflammation in abdominal obese participants. METHOD: This multi-center study was conducted using a 2.5-month parallel total-blind randomized clinical trial design. Two hundred and eighty nine subjects were allocated to four groups: low-fat milk fortified by 1500 IU nano-encapsulated vitamin D3 (200 mL/day). Simple milk (200 mL/day), low-fat yogurt fortified by 1500 IU nano-encapsulated vitamin D3 (150 g/day), and simple yogurt (150 g/day). RESULTS: The results showed that serum levels of neutrophils, lymphocytes, platelets and red blood cell distribution width (RDW) were significantly lower before and after the intervention in fortified dairy groups. The results showed that serum levels of neutrophils, lymphocytes, platelets, and RDW before and after intervention in the fortified dairy groups were significantly lower (p < 0.05). The values of = neutrophil to lymphocyte ratio (NLR), platelets to lymphocyte ratio, and RDW to platelets ratio (RPR) reduced significantly in the fortification group (p < 0.05). CONCLUSION: Fortification with nano-encapsulated vitamin D3 of dairy products may decrease inflammation in individuals with abdominal obesity.

The effects of high dose vitamin D supplementation as a nutritional intervention strategy on biochemical and inflammatory factors in adults with COVID-19: Study protocol for a randomized controlled trial.

Introduction: Low serum vitamin D has been shown to be a risk factor for Coronavirus 2019 (COVID-19). The aim of this study was to assess the effects of high dose vitamin D supplementation on hs-CRP, ESR and clinical outcomes, including duration of hospitalization, quality of life and New York Heart Association (NYHA) Functional Classification, in adults with COVID-19. Methods: This double-blind, randomized control trial will be conducted on patients with RT-PCR and/or chest CT scan diagnosis of COVID-19 admitted in Imam Reza Hospital, Mashhad, Iran. Participants will be randomized into control and intervention groups based on randomization sampling. The intervention group will receive soft gel containing 50,000 IU vitamin D on the first day followed by 10,000 IU/day through a supplement drop daily for 29 days. The control group will receive 1000 IU vitamin D daily through supplement drop and a placebo soft gel. All participants will undergo laboratory assessment including inflammatory markers, serum 25)OH)D, complete blood count (CBC), liver and renal profile, lipid profile and erythrocyte sedimentation rate (ESR) at baseline and at day 30. The mortality rate will be recorded in both groups. Results: Data will be presented using descriptive statistics. Comparison of changes in study parameters over the study period will be performed using analysis of covariance adjusting for possible confounders. Conclusions: The findings of this will provide evidence on the effects of high dose vitamin D supplementation on inflammatory markers in hospitalized COVID-19 patients.

The effects of consuming a low-fat yogurt fortified with nano encapsulated vitamin D on serum pro-oxidant-antioxidant balance (PAB) in adults with metabolic syndrome; a randomized control trial.

BACKGROUND AND AIM: The current study aimed to assess the effect of fortified yogurt with nano-encapsulated vitamin D on serum pro-oxidant anti-oxidant balance (PAB) in adults with or without metabolic syndrome. METHODS: In a quadruple blind clinical trial study, 139 adults with an age range of 30-50 years were randomly selected to receive either 1500 IU nano-encapsulated vitamin D fortified yogurt or placebo for ten weeks. Before and after the intervention period, blood sample was taken to determine the serum levels of vitamin D, pro-oxidant-antioxidant balance (PAB), and high-sensitivity C-reactive protein (hs-CRP). The laboratory tests were checked at baseline and at the end of the treatment. RESULTS: Serum vitamin D increased significantly, from 14.47 ± 6.07 ng/mL to 21.39 ± 6.54 ng/mL (P < 0.001) after ten weeks in the intervention group. Serum hs-CRP and PAB were significantly lower following consumption period in intervention group [1.95(0.4-8.15) g/dL vs. 1.35(0.25-3.62) g/dL; P = 0.013] and (135.19 ± 42.4 HK vs. 115.39 ± 44.69) HK; P = 0.018] respectively. There were no significant differences between the intervention and control groups regarding weight and BMI at the end of the intervention period (p > 0.05). CONCLUSION: Low-fat yogurt fortified with nano-encapsulated vitamin D was found to reduce serum PAB levels in adults with metabolic syndrome. PRACTICAL APPLICATION: The findings of the present study indicated that a low-fat yogurt fortified with 1500 IU nano-encapsulated vitamin D for ten weeks, leads to a significant reduction in serum hs-CRP and PAB concentrations highlighted the anti-inflammatory/anti-oxidative effect of vitamin D.

Effect of low-fat dairy products fortified with 1500IU nano encapsulated vitamin D3 on cardiometabolic indicators in adults with abdominal obesity: a total blinded randomized controlled trial.

BACKGROUND & AIMS: Vitamin D deficiency is widespread worldwide. In this study, we aimed to evaluate the effect of a nano encapsulated form of vitamin D used for fortifying low-fat dairy products (milk and yogurt) on anthropometric indices, glycemic status, and lipid profile in subjects with abdominal obesity. METHODS: In a totally (quadruple) blinded, randomized, and parallel-controlled trial, 306 individuals with abdominal obesity were randomly allocated to one of four groups: fortified low-fat yogurt (FY, 1500 IU nano encapsulated vitamin D3 per 150 g/d), non-fortified low-fat yogurt (nFY), fortified low-fat milk (FM, 1500 IU nano encapsulated vitamin D3 per 200 g/d), non-fortified low-fat milk (nFM), for 10 weeks (nFM and nFY, were considered as the control groups). Anthropometric and biochemical parameters were measured at baseline and after a ten-week trial in Mashhad, Iran. RESULTS: After the ten-week intervention, we found a significant increase in serum concentration of 25(OH)D in both the FM and FY groups compared to the respective control groups (19.10 ± 5.69 ng/mL and 20.88 ± 5.76 ng/mL respectively, p < .001). We observed a significant reduction in weight to hip ratio (p = .04) and a significant improvement in triglyceride (p < .001) and HDL-C (p = .01) only in FM group compared to nFM group. Also, we found a significant reduction in fasting serum insulin (p < .001), and a significant improvement of HOMA-IR (p < .001) and QUICKI (p < .001) in both intervention groups compared to their placebos. CONCLUSIONS: An intake of fortified dairy products containing nano-encapsulated vitamin D3 was associated with an improvement in some measures of anthropometric indices, glucose homeostasis, and lipid profiles, particularly in individuals receiving fortified milk. Hence, along with other benefits, fortification of dairy products with vitamin D may be an effective approach to improve some cardiometabolic indicators, such as insulin resistance. TRIAL REGISTRATION NUMBER: IRCT20101130005280N27.

Effect of high-dose vitamin D supplementation on antibody titers to heat shock protein 27 in adolescent girls.

Background Although vitamin D deficiency is associated with several inflammatory conditions, there have been few studies on the effects of vitamin D supplementation on markers of oxidative stress (OS) and inflammation. The aim of the current study was to evaluate the effects of high-dose vitamin D supplementation on heat shock protein 27 antibody (anti-Hsp27) titers in adolescent girls. Methods Five hundred and fifty adolescent girls received vitamin D3 at a dose of 50,000 IU/week for 9 weeks. Demographic, clinical and biochemical markers including serum fasting blood glucose (FBG), lipid profile and anti-Hsp27 titers as well as hematological parameters including white blood cell (WBC) count and red blood cell (RBC) distribution width (RDW) were determined in all the subjects at baseline and at the end of the study. Results Serum vitamin D significantly increased from 6.4 (4.2-9.6) ng/mL to 35.6 (25.8-47.5) ng/mL (p < 0.001) following the intervention. Furthermore, serum anti-Hsp27 titers were significantly lower after the 9-week vitamin D administration period (0.22 [0.12-0.33] optical density [OD] vs. 0.19 [0.11-0.31] OD; p = 0.002). A significant correlation was found between serum anti-Hsp27 and RDW (r = 0.13, p = 0.037). The reduction in RDW values after intervention was particularly evident in subjects with the greatest increase in serum vitamin D levels. Conclusions High-dose vitamin D supplementation was found to reduce antibody titers to Hsp27. Further randomized placebo-controlled trials are warranted to determine the long-term effect of vitamin D administration on the inflammatory process especially that associated with chronic disease.

Crocus sativus a natural food coloring and flavoring has potent anti-tumor properties.

BACKGROUND: Saffron, the dried stigmas of Crocus sativus L., is a highly valued agricultural product that is used mainly as a food coloring and flavoring agent. Three main secondary metabolites of Crocus sativus including crocin, picrocrocin, and safranal are responsible for the color, the bitter taste and for the odor and aroma, respectively. As a component of traditional medicine, saffron has been utilized as a medicinal herb for treating various ailments including cramps, asthma, liver disease, menstruation disorders, pain, and in the pathogenesis of cancer. HYPOTHESIS/PURPOSE: To summarize the recent published data on the chemo-preventive properties of Crocus sativus in cancer treatment. STUDY DESIGN: We conducted a non-systematic review of the literature. METHODS: A search of English-language literature was performed using Scopus, EMBASE and PubMed. We applied no restriction in time. Articles were searched using the keywords "Lung", "breast", "skin", "prostate", "leukemia", "cancer", "neoplasm", "tumor", "malignancy", "saffron", "crocus sativus", "crocin", "crocetin", "picrocrocin", and "safranal". RESULTS: Saffron has been reported to exert anti-tumor and anti-cancer effects in various types of cancer including lung cancer, breast cancer, leukemia, skin cancer and prostate cancer. This appears to be via various mechanisms including: the induction of apoptosis, arresting cell cycle progression, suppressing expression of matrix metalloproteinase, modulatory effects on some phase II detoxifying enzymes and decreasing expression of inflammatory molecules are potential mechanisms of saffron-induced anticancer effects. CONCLUSION: Saffron possesses potent anti-tumor properties and represents an efficacious and safe treatment.