This research aimed to evaluate the effects of high-dose cholecalciferol (VD₃) supplements (50,000 IU/week) on selected circulating cytokines associated with cytokine storms in adults with vitamin D deficiency. This clinical trial, based in Jordan, included 50 participants receiving vitamin D₃ supplements (50,000 IU/week) for 8 weeks; the exact number was assigned to the control group. Interleukin-6 (IL-6), interleukin-1β (IL-1β), interleukin-10 (IL-10), tumor necrotic factor-α (TNF-α), and leptin were measured in serum at baseline and 10 weeks (wash out: 2 weeks). Our results revealed that vitamin D₃ supplementation significantly increased the serum levels of 25OHD, IL-6, IL-10, IL-1β, and leptin compared with baseline. In contrast, the serum level of TNF-α insignificantly increased in the group receiving vitamin D₃ supplementation. Although the observations of this trial may refer to a potential negative effect of VD₃ supplementation during cytokine storms, further trials are required to clarify the potential benefits of VD₃ supplement during cytokine storms.

Purpose This randomized clinical trial (RCT) was created to assess the influence of 1,25-dihydroxyvitamin D (VD₃), omega−3 fatty acids (n-3FA), and their combination (D+) on glycated hemoglobin (A1c) levels in Jordanian peoples with vitamin D deficiency (VDD). Participants and Methods This RCT was designed to examine the follow-up (2 months) effect of either 50,000 IU VD₃, 300 mg n-3FA, or the combination of the two supplements on glycated Hemoglobin (A1c) levels in 146 Jordanian women and men with VDD, aged from 25 to 55 years. The eligible participants were randomized into 4 groups: Control (C); VD₃ supplementation (50,000 IU of VD₃ was taken weekly) (D₃); n-3FA supplementation (300 mg of Omega-3FA was taken daily) (n-3FA); VD₃ and omega 3 supplementation group (D+) with the same protocol as the previous two groups. Results The combination therapy (n-3FA plus VD3) for 8 weeks significantly increased A1c levels (5.79±0.34 vs. 5.41±0.33, P<0.001). Tukey test for post-hoc comparisons of A1c at follow-up showed that the A1c mean levels were remarkably higher in the D+ study group comparing to the control group (5.78 vs. 5.38). Conclusion The intervention of n-3FA alone or in combination with high doses of VD₃ may lead to negative effects on glycemic control or accelerate the insulin resistance’s development in susceptible people for diabetes mellitus (type 2).

Purpose: Studies on the effect of body weight and coffee consumption on leptin, vitamin B12, and folic acid are scarce and conflicting. This study investigates the effect of body weight and/or coffee consumption rate on the serum levels of these molecules in healthy young adult males. Patients and Methods: This observational cross-sectional study was carried out at the faculty of pharmacy, Applied Science Private University (ASU), Amman, Jordan, from July to September 2020. Young healthy males were invited to participate in the study and fill a questionnaire regarding lifestyle habits including coffee consumption during the last 3 months, medical history, and anthropometric measurements. Depending on BMI and extent of coffee consumption, participants were divided into 4 groups; normal body weight and moderate coffee consumption (NW/MCC) group; normal body weight and heavy coffee consumption (NW/HCC) group; overweight and moderate coffee consumption (OW/MCC) group; overweight and heavy coffee consumption (OW/HCC) group. Serum samples were taken to measure leptin, vitamin B12, and folic acid levels in addition to morning and midnight salivary cortisol and dehydroepiandrosterone (DHEA) samples. Results: Healthy males (n = 122) aged 18 to 26 years continued participation in this study. Serum levels of leptin in NW/MCC, NW/HCC, OW/MCC, OW/HCC groups were 5.93, 5.75, 14.86, 16.79 ng/mL, respectively. Serum levels of vitamin B12 in these groups were 356.09, 402.71, 334.25, 331.05 pg/mL, respectively. While, the serum levels of folic acid were 8.92, 10.27, 10.12, 10.47 ng/mL, respectively. Body weight was positively associated with leptin (p = 0.00), negatively associated with vitamin B12 (p = 0.047), and not associated with folic acid (p = 0.235). Coffee consumption rate had no significant effect on leptin, vitamin B12, or folic acid. Finally, the combination of body weight and coffee consumption had no significant effect on leptin, vitamin B12, or folic acid. Conclusion: There was no possible synergistic effect between body weight and coffee consumption rate on leptin, vitamin B12, or folic acid levels. However, overweight was associated with higher leptin, lower vitamin B12, and no change in folic acid levels. Trial Registration: This trial was registered at clinicaltrials.gov as NCT04488731.

Objective: To investigate the associations of coffee consumption and/or smoking on certain clinical outcomes including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), vitamin B12, and folic acid in a population of young healthy men. Method: This cross-sectional study was conducted in Amman, Jordan, over 4 months. Participants were approached for study participation and asked to fill a questionnaire about their anthropometric information, habitual smoking, and coffee consumption during the last 3 months. Their fasting blood samples were taken to measure TC and LDL-C. Results: Healthy male participants (n=117) in the age range of 18 to 26 years were recruited. Mean serum TC was higher in heavy coffee consumers (C++) group (≥3 cups/day) with or without smoking (M= 179.9±34.59 mg/dL and 195.94±23.69 mg/dL) in comparison with moderate coffee consumers (C+) group (1–2 cups/day) (M= 158.1±24.82 mg/dL and 177.23±34.17 mg/dL), and the mean level was higher in subjects who were coffee consumers only than smokers who were coffee consumers. LDL-C levels were higher in participants who were coffee consumers (M= 103.06±34.82mg/dL and 118.06±19.31 mg/dL) than smokers who were coffee consumers (M= 88.6±22.40 mg/dL and 108.26±37.57 mg/dL). No significant difference was noted regarding HDL-C, vitamin B12, and folic acid. Conclusion: Our findings showed that heavy coffee consumption was more associated with hyperlipidemia than cigarette smoking. Accordingly, we conclude that moderate coffee consumption may reduce the risk of cardiovascular diseases or their consequences in male.

Purpose: Outcomes investigating the effect of vitamin D3 (VD3) and omega-3 fatty acids (Omega-3FA) on serum estradiol (E2) are scarce and conflicting. No previous study has investigated the effect of VD3 combination with Omega-3FA on E2 levels. This study was designed to investigate the effect of VD3, Omega-3FA and VD3 plus Omega-3FA on serum E2 levels in premenopausal females diagnosed with vitamin D deficiency (VDD). Subjects and methods: This randomized, placebo-controlled clinical trial was designed to evaluate the effects of 50,000 IU VD3 taken weekly, 300 mg Omega-3FA taken daily and their combination by the study participants for 8 weeks. The mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD) were assessed at 8 weeks. The study was conducted during winter on a convenience sample of healthy premenopausal Jordanian females with diagnosed VDD. Fasting serum levels for 25OHD and E2 were assessed at baseline and the end of the trial (after 8 weeks). Data were entered into SPSS and analyzed. Results: Healthy premenopausal Jordanian females (N=86) with diagnosed VDD, mean age 32.8±8.9 years, were recruited into the study. Supplementation of VD3 alone resulted in a significant increase in serum 25OHD (13.4±7.9–28.2±7.1 ng/mL, P<0.001) and a significant decrease in E2 levels (85.7±16.5–60.3±20.6 pg/mL, P=0.001). Omega-3FA intake led to a significant decrease in serum 25OHD levels (21.2±12.8–13.6±9.2 ng/mL, P=0.001) and a significant increase in E2 levels (56.3±19.2–78.4±23.7 pg/mL, P=0.006). Combination therapy (VD3 plus Omega-3FA) resulted in a significant increase in both 25OHD (12.0±4.7–35.1±9.5 ng/mL, P<0.001) and E2 (43.0±23.4–57.3±31.5 pg/mL, P=0.028) levels. Conclusion: Results of this study provide vital insight into the effects of D3, Omega-3FA and a combination of their supplementation on premenopausal Jordanian females with diagnosed VDD. Eight weeks of therapy led to decreased E2 level by VD3 and increased level by Omega-3FA supplementation. With regard to 25OHD, its level was increased by VD3 and decreased by Omega-3FA supplementation. Combination of VD3 plus Omega-3FA increased the levels of both E2 and 25OHD. Trial registration: This trial was registered at clinicaltrials.gov as NCT03333564.

Objective: The aim of this randomized controlled clinical trial was to determine the effect of the omega-3 fatty acid supplementations 300 mg per day for 8 weeks on the serum levels of ACE/ACE2 ratio in Jordanian participants with vitamin D deficiency (VDD). Methods: The physical and clinical characteristic of individuals in both intervention and control randomized controlled clinical trial were measured and analyzed. The comparisons between the two groups and the changes in each group before and after taking omega-3 doses were studied through independent t test and paired t test, respectively. Possible factors that have a role in the changes were determined by multivariate stepwise regression. Follow-up period lasted 10 weeks. Results: The sample consisted of 82 participants with VDD and a mean age of 37.85 ± 9.85 years. Omega-3 Supplements resulted in a significant decrease in serum ACE levels, ACE/ACE2 ratio and serum 25-hydroxy vitamin D (25OHD). While the change in serum ACE2 levels and serum triglycerides levels were insignificant. Also, a significant increase in serum LDL levels were observed. Conclusion: It is possible that taking high doses of omega-3 fatty acid supplementations have positive effects on the heart and circulatory system and could protect from COVID-19 or decrease disease severity, in connection with a decrease in the ACE/ACE 2 ratio. On the other hand, omega-3 supplement may have negative effect on cardiovascular system due to the significant increase in serum LDL levels.