Sumac (Rhus coriaria L.) powder supplementation has beneficial effects on appetite in overweight/obese women with depression: A randomized controlled trial.

BACKGROUND AND PURPOSE: Appetite disturbance is a common problem in obesity and depression. The beneficial effects of polyphenols in promoting satiety have been shown. This study aimed to investigate the effects of sumac supplementation along with calorie restricted diet (CRD) on appetite in overweight and obese women with depression. MATERIALS AND METHODS: In this trial, 60 overweight and obese women with depression were randomly assigned to receive a CRD plus 3 g/day of either sumac or placebo for 12 weeks. The appetite score, serum levels of leptin, neuropeptide Y (NPY), insulin, fasting blood sugar (FBS), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI) were assessed at baseline and at the end of the study. RESULTS: Sumac supplementation significantly reduced the appetite score (p = 0.02), serum levels of leptin (p = 0.03), NPY (p = 0.01), insulin (p = 0.03), FBS (p = 0.03), and HOMA-IR (p = 0.02) compared to the placebo group. QUICKI increased significantly in the sumac group compared to the placebo group (p = 0.009). CONCLUSION: Sumac along with a CRD may have some beneficial effects on appetite through possible modulatory effects on leptin resistance, insulin sensitivity, and NPY levels in overweight and obese women with depression.

Vitamin D, testosterone and depression in middle-aged and elderly men: a systematic review.

Depression is one of the common psychiatric disorders during elderly. This systematic review aims to present the relationship between vitamin D deficiency, depression and testosterone serum concentration in the middle-aged and elderly men. We performed a comprehensive search in the Google Scholar, PubMed, ProQuest, Web of Science, Cochrane, Science Direct, and Scopus databases to collect any relevant published studies. The data of the articles that had been investigated the relationship between depression and 25-hydroxy vitamin D (25[OH]D) serum concentration (nine studies), or testosterone and 25[OH]D (six studies), as the primary outcomes, were included in our review. The results of the cohort and cross-sectional studies have shown that vitamin-D deficiency is associated with the incidence of depression in older men. In addition, documents have reported the positive association between vitamin D and testosterone, and previous studies have shown that testosterone can involve in the mood. We have proposed scientific mechanisms that have shown vitamin D may also play a protective role in depression through its effect on the testosterone. Therefore, it is a low risk and safe recommendation for the middle-aged and elderly men to use the vitamin D supplement or exposure to the sunlight to prevent depression.

The effect of synbiotic and vitamin D co-supplementation on body composition and quality of life in middle-aged overweight and obese women: A randomized controlled trial.

BACKGROUND & AIMS: Obesity is a worldwide problem which has involved large populations. Since some dietary factors might modify obesity through various signaling pathways, the aim of this study was to investigate the effect of synbiotic plus vitamin D co-supplementation on body composition parameters and quality of life, in middle-aged overweight and obese women. METHODS: A randomized, controlled, double-blinded trial was performed and 88 overweight and obese women were assigned to 4 groups (22 per group), receiving synbiotic plus vitamin D, synbiotic, vitamin D and placebo for 8 weeks. At the beginning and at the end of the trial, anthropometric indices, body composition indicators, physical activity level, dietary intake, and quality of life score were measured by trained nutritionists. Statistical analysis was performed with SPSS version 22. RESULTS: The results showed significant difference between 4 groups in waist circumference (WC), fat mass (FM), body fat percentage (BFP) and visceral fat area (VFA) values after 8 weeks of treatment (P = 0.005, P = 0.007, P = 0.003, and P = 0.009, respectively), with the greatest reduction in synbiotic plus vitamin D group compare to placebo. No significant results were demonstrated between groups in relation to other body composition variables. In addition, there were no significant differences between the 4 groups regarding physical, mental and total aspects of life quality over time. CONCLUSIONS: Our study demonstrated that synbiotic and vitamin D co-supplementation for 8 weeks, had favorable effect on various anthropometric indices and body composition indicators, but no desirable change in life quality score. CLINICAL TRIAL REGISTRY: IRCT (registration no. IRCT20090822002365N25).

The effects of synbiotic and/or vitamin D supplementation on gut-muscle axis in overweight and obese women: a study protocol for a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Sarcopenia refers to an age-related loss of skeletal muscle content, strength, and function, leading to a decrease in mobility. Obesity may exacerbate age-related complications such as sarcopenia through inflammatory pathways. In addition, intestinal dysbiosis has been proposed as an emerging contributor to sarcopenia due to the stimulation of the immune system and elevated barrier permeability of the intestine. Targeting microbiome with synbiotic and vitamin D supplementation may modulate the microbiome followed by the enhancement of sarcopenia indices. Thus, the present study aims to evaluate the effect of synbiotic supplementation with or without vitamin D on the intestinal microbiome and its relationship with strength, muscle function, and body composition in middle-aged overweight and obese women. METHODS: This multi-factorial, double-blind, randomized controlled trial will be conducted on 88 participants in eight weeks. The participants will be allocated into four groups receiving vitamin D placebo (weekly) and synbiotic placebo (daily), vitamin D and synbiotic placebo, vitamin D placebo and symbiotic, and vitamin D and synbiotic. Intestinal microbiome assessment will be done by DNA isolation and real-time polymerase chain reaction (PCR). In addition, anthropometric indices, body composition, muscle strength, and physical performance will be evaluated by standard methods. All measurements will be made at the beginning and end of the study. DISCUSSION: The previous studies showed that probiotics were involved in reducing inflammation, insulin sensitivity, modulation of atrophy markers such as atherogen-1, and decreasing reactive oxygen indices. In addition, vitamin D was found to improve the intestinal microbiome and facilitate muscle anabolism. The present protocol is novel as it aims to investigate the impact of the co-supplementation of synbiotic and vitamin D on the gut microbiome and sarcopenia indices. TRIAL REGISTRATION: This trial has been registered in the Iranian Registry of Clinical Trials (IRCT20090822002365N25, date of registration: March 2021).

Randomized study of the effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammation, and SIRT1 in obese women with mild to moderate depressive symptoms.

OBJECTIVES: This study aimed to evaluate the effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammation, and SIRT1 in obese women with mild to moderate depressive symptoms. METHODS: In this trial, the 108 obese women with mild to moderate depressive symptoms were randomly allocated into 4 groups: (1) co- supplementation group (n = 27): receiving a 50000 IU vitamin D soft gel weekly + a 250- mg magnesium tablet daily; (2) vitamin D group (n = 27): receiving a 50000 IU vitamin D soft gel weekly + a magnesium placebo daily; (3) magnesium group (n = 27): receiving a vitamin D placebo weekly + a 250- mg magnesium tablet daily; (4) control group (n = 27): receiving a vitamin D placebo weekly + a magnesium placebo daily, for 8 weeks. Before and after the intervention, anthropometric indices, depressive symptoms, serum levels of BDNF, 25(OH)-D, inflammation, and SIRT1, were measured. RESULTS: At the end of the study, ANCOVA demonstrated significant differences between the 4 groups in 25(OH)-D, magnesium, TNF-α, IL-6, and BDNF levels. But, we found no significant differences in terms of hs-CRP and SIRT1 levels. A significant reduction in depression score was observed in 3 intervention groups and also in control group. No significant differences in BDI-II score were shown among the 4 groups at the end of the intervention. CONCLUSION: Vitamin D plus magnesium supplementation in obese women with mild to moderate depressive symptoms has beneficial influences on mood, serum levels of BDNF, inflammation, and SIRT1.

Testing the Effects of Cinnamon Extract Supplementation on Inflammation and Oxidative Stress Induced by Acrylamide.

We investigated the effects of cinnamon water extract supplementation on inflammation and oxidative stress induced by acrylamide in rats. This revealed acrylamide-intoxicated control group had significant higher levels of malondialdehyde, tumor necrosis factor-alpha (TNF-α), high-sensitive C-reactive protein (hs-CRP), leptin and alanine transaminase, and lower levels of total antioxidant capacity compared to the negative control group. In contrast, cinnamon extract administration remedied the levels of total antioxidant capacity, malondialdehyde, TNF-α, hs-CRP, and leptin in the treatment groups. However, there was no significant effect on adiponectin or liver enzymes. This chapter presents a protocol involving production of the acrylamide-induced oxidative stress model, the aqueous extraction of cinnamon powder, and measurement of inflammatory and oxidative stress markers.

Testing the Physical and Molecular Effects of Nutritional Supplements and Resistance Exercise in Middle-Aged Females.

Aging results in loss of muscle mass and strength, which are linked to development of metabolic disorders such as insulin resistance, obesity, and type 2 diabetes mellitus. A number of studies have now shown that these effects can be ameliorated by dietary supplementation with natural products such as vitamins, omega-3 fatty acids, and protein and by physical activities such as aerobic and resistance exercise. Here, we present a protocol for setting up a trial to test the effects of vitamin D and omega-3 fatty acid supplementation and resistance exercise on various anthropometric and molecular measurements in middle-aged females.

Impact of coenzyme Q10 on inflammatory biomarkers and its role in future therapeutic strategies.

Coenzyme Q (CoQ) is an important component of the mitochondrial electron transport chain. The finding that multiple chronic diseases show lower levels of CoQ10 has led to the possibility that CoQ10 supplementation could be an effective approach to ameliorate or prevent disease progression. In this review, we discuss the state of the art regarding the role of CoQ10 in health and disease and describe the latest clinical studies which have tested the effects of CoQ10 supplementation in inflammatory diseases. The results of these studies indicate that individuals suffering from inflammation-related diseases show improvement under the CoQ10 supplementation protocol. However, these results have been inconsistent, leading to the need for additional studies at the preclinical and clinical levels, involving a greater number of subjects and different treatment regimes.

Randomized Study of the Effects of Zinc, Vitamin A, and Magnesium Co-supplementation on Thyroid Function, Oxidative Stress, and hs-CRP in Patients with Hypothyroidism.

Hypothyroidism can occur due to deficiencies in micronutrients such as zinc, magnesium, and vitamin A. The aim of this study was to determine the effects of supplementation with these micronutrients on thyroid function, oxidative stress, and hs-CRP levels in patients with hypothyroidism. In a randomized double-blind, placebo-controlled trial with two parallel groups, 86 hypothyroid patients aged 20-65 were allocated to receive daily supplementation with either: (intervention group, n = 43) one 30 mg zinc gluconate capsule per day, one 250 mg magnesium oxide tablet per day, and one 25,000 IU vitamin A capsule twice/week for 10 weeks or (placebo group, n = 43) placebo capsules and tablets as above for 10 weeks. Neither of the groups changed their diet or physical activity. Thyroid hormones (free and total thyroxine (FT4 and TT4), free tri-iodothyronine (FT3), and thyroid-stimulating hormone (TSH)), oxidative markers (malondialdehyde (MDA) and total antioxidant capacity (TAC)), serum hs-CRP, and anthropometric indices (height and weight) were assessed at the baseline and at the end of the study. In the intervention group, we found a significant increase in serum FT4, decreased anthropometric indices, and lower levels of serum hs-CRP by the end of the 10 week protocol (P < 0.05). In the placebo group, serum TAC was decreased and hs-CRP increased (P < 0.05), with no significant changes in serum TSH, FT3, TT4, and MDA after the intervention. Zinc, vitamin A, and magnesium supplementation may have beneficial effects in patients with hypothyroidism and in diseases associated with hyperthyroidism.

Randomized Study of the Effects of Vitamin D and Magnesium Co-Supplementation on Muscle Strength and Function, Body Composition, and Inflammation in Vitamin D-Deficient Middle-Aged Women.

This study aimed to investigate the effects of vitamin D and magnesium co-supplementation on muscle strength and function, body composition, and inflammation in vitamin D-deficient middle-aged women. In this study, 83 healthy middle-aged women (40-55 years) with vitamin D deficiency were randomly assigned into two groups: (1) intervention: receiving a 50,000-IU vitamin D soft gel (weekly) plus a 250-mg magnesium tablet (daily); (2) control: receiving a vitamin D placebo (weekly) plus a magnesium placebo (daily), for 8 weeks. Before and after the intervention, anthropometric indices, muscle strength, muscle function, and some inflammatory markers were measured. After 8 weeks of supplementation, significant difference was observed in handgrip strength and time for Time Get Up and Go (TGUG) test between the intervention and placebo groups (P < 0.05). Regarding percentage of fat mass (FM%) and fat free mass (FFM%), and knee extension strength, there was no significant difference between the two groups at the end of intervention (P > .05). Serum 25(OH)-D levels increased significantly (P < 0.001) and its change was significantly different between the two groups, at the end of the intervention (P < 0.001). Serum level of hs-CRP decreased significantly in the intervention group compared to baseline (P < 0.001), and the change in hs-CRP was significant between the two groups at the end of the intervention (P < 0.01). Furthermore, serum level of TNF-α declined significantly in the intervention group compared to baseline (P < 0.001) but, no significant differences were seen between the two groups in regard of serum levels of TNF-α and IL-6 after the intervention (P > 0.05). Our findings show that vitamin D and magnesium co-supplementation, for 8 weeks, in healthy middle-aged women with vitamin D deficiency have beneficial impacts on muscle strength, muscle function, and probably inflammation.

Changes in Bone Turnover, Inflammatory, Oxidative Stress, and Metabolic Markers in Women Consuming Iron plus Vitamin D Supplements: a Randomized Clinical Trial.

We aimed to investigate whether combination of vitamin D and iron supplementation, comparing vitamin D alone, could modify bone turnover, inflammatory, oxidative stress, and metabolic markers. Eighty-seven women with hemoglobin (Hb) ≤ 12.7 g/dL and 25OHD ≤ 29 ng/mL vitamin D deficiency/insufficiency aged 18-45 years were randomly assigned into two groups: (1) receiving either 1000 IU/day vitamin D3 plus 27 mg/day iron (D-Fe); (2) vitamin D3 plus placebo supplements (D-P), for 12 weeks. In D-Fe group, significant decrease in red blood cells (RBC) (P = 0.001) and hematocrit (Hct) (P = 0.004) and increases in mean corpuscular hemoglobin concentration (MCHC) (P = 0.001), 25OHD (P < 0.001), osteocalcin (P < 0.001), high-density cholesterol (HDL) (P = 0.041), and fasting blood sugar (FBS) (P < 0.001) were observed. D-P group showed significant decrease in RBC (P < 0.001), Hb (P < 0.001), Hct (P < 0.001), mean corpuscular volume (MCV) (P = 0.004), mean corpuscular hemoglobin (MCH) (P < 0.001), MCHC (P = 0.005), serum ferritin (P < 0.001), and low-density cholesterol (LDL) (P = 0.016) and increases of 25OHD (P < 0.001), osteocalcin (P < 0.001), C-terminal telopeptide (CTX) (P = 0.025), triglyceride (TG) (P = 0.004), FBS (P < 0.001), and interleukin-6 (IL-6) (P = 0.001) at week 12. After the intervention, the D-P group had between-group increases in mean change in the osteocalcin (P = 0.007) and IL-6 (P = 0.033), and decreases in the RBC (P < 0.001), Hb (P < 0.001), Hct (P < 0.001), and MCV (P = 0.001), compared with the D-Fe group. There were significant between-group changes in MCH (P < 0.001), MCHC (P < 0.001), ferritin (P < 0.001), and serum iron (P = 0.018). Iron-vitamin D co-supplementation does not yield added benefits for improvement of bone turnover, inflammatory, oxidative stress, and metabolic markers, whereas, vitamin D alone may have some detrimental effects on inflammatory and metabolic markers. IRCT registration number: IRCT201409082365N9.

Vitamin C and Cancer: The Role of Vitamin C in Disease Progression and Quality of Life in Cancer Patients.

Much attention has been put on antioxidants as potential preventive and therapeutic agents against cancer. Vitamin C, an important antioxidant with anti-inflammatory and immune system enhancement features, could provide protection against cancer. However, experimental and epidemiologic evidence on vitamin C and cancer risk are still indefinite. Substantial literature reports that cancer patients experience vitamin C deficiency associated with decreased oral intake, infection, inflammation, disease processes, and treatments such as radiation, chemotherapy, and surgery. Studies demonstrate associations between IVC and inflammation biomarkers and propose some amelioration in symptoms, with a possible advantage in quality of life (QoL) when intravenous vitamin C (IVC) alone or in combination with oral vitamin C is administered in oncologic care. While, the anticancer impact of high doses of IVC remains debatable in spite of growing evidence that high dose vitamin C shows anti-tumorigenic activity by elevating the amount of reactive oxygen species (ROS) in cancer cells without meaningful toxicities. Hence, there is an urgent requirement for rigorous and well-controlled assessments of IVC as an adjuvant therapy for cancer before clear conclusions can be drawn. Thus, more clinical trials are required to determine the additive impact of high dose vitamin C in cancer patients.

Effects of Vitamin D and Omega-3 Fatty Acids Co-Supplementation on Inflammatory Factors and Tumor Marker CEA in Colorectal Cancer Patients Undergoing Chemotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Objectives: This study aimed to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory factors and tumor marker CEA in colorectal cancer patients undergoing chemotherapy.Methods: In this study, 81 patients with stage ӀӀ or ӀӀӀ colorectal cancer were randomly assigned into four groups: (1) control: receiving a vitamin D placebo, weekly + two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids), daily + a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acids capsules, for 8 weeks. Before and after the intervention, serum levels of 25(OH)D, TNF-α, IL-1ß, IL-6, IL-8, NF-kB activity, and tumor marker CEA, were measured.Results: After 8 weeks of intervention, patients who received combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo had significantly decreased TNF-α, and IL-1ß (P < .05). In addition, serum levels of TNF-α, IL-1ß, IL-6, IL-8, and tumor marker CEA were decreased significantly in omega-3, vitamin D, and co-supplementation of them, compared with baseline. NF-kB activity was decreased significantly in vitamin D and co-supplementation groups, compared with baseline. Regarding CEA, there was no significant difference between the four groups at the end of intervention (P > .05).Conclusion: Results show that co-supplementation of vitamin D and omega-3 fatty acids co-supplementation, in colorectal cancer patients have beneficial impacts on inflammation and tumor marker CEA.

Micronutrients that Affect Immunosenescence.

The immune system undergoes some adverse changes throughout aging, many of which have been implicated in the increased morbidity and mortality related to infection in the elderly. In addition to intrinsic alterations in the immune system with aging, the elderly are more likely to have poor nutritional status, which further affects the already impaired immune function. Micronutrient deficiencies are a recognized global public health problem, and poor nutritional status predisposes to certain infections. Immune function may be ameliorated by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. This review looks at the effects of micronutrient supplementation on immune function during aging.

Randomized Study Design to Test Effects of Vitamin D and Omega-3 Fatty Acid Supplementation as Adjuvant Therapy in Colorectal Cancer Patients.

This study examines the effects of vitamin D and omega-3 fatty acid co-supplementation on inflammation and nutritional status in colorectal cancer patients. Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D3) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks. As outcomes, we measure height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin, before and after the intervention. The presented results show that vitamin D3 plus omega-3 fatty acid co-supplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

Effect of Vitamin D Supplementation on Muscle Strength, Muscle Function, and Body Composition in Vitamin D-Deficient Middle-Aged Women.

Sarcopenia is the loss of muscle strength and muscle mass with aging and is one of the major risk factors for metabolic diseases. Cross-sectional studies have shown that vitamin D is associated with sarcopenia in both men and women. We investigated the effect of vitamin D supplementation over 12 weeks on muscle strength, muscle function, and body composition in middle-aged women in randomized double-blind placebo-controlled trial format. This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups. In addition, handgrip strength was improved, and the timed get up and go (TGUG) test and body fat content were decreased. This chapter presents a protocol for trial setup involving measurement of vitamin D levels, handgrip strength, the TGUT test, and body composition as readouts.

Effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammatory biomarkers, and SIRT1 in obese women: a study protocol for a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Emerging evidence has shown that vitamin D and magnesium have anti-inflammatory and anti-depressant effects. Dietary intake of magnesium is associated with reduced body mass index, waist circumference, body fat percentage, as well as inflammatory biomarkers and depressive symptoms. Vitamin D deficiency has been linked to inflammation, obesity, and depressive symptoms. This study will test the effects of vitamin D and magnesium co-supplementation on mood, serum level of brain-derived neurotrophic factor (BDNF), inflammation, and sirtuin 1 (SIRT1) in obese women. METHODS: We will conduct an 8-week, double-blind, randomized, placebo-controlled clinical trial, in a factorial design, to evaluate the individual effects of vitamin D and magnesium, and co-supplementation of them, on mood, serum level of BDNF, inflammation, and SIRT1 in 108 obese women. DISCUSSION: We hypothesize that vitamin D and magnesium co-supplementation may provide a new adjuvant therapy through modulation of BDNF, inflammation, and SIRT1 in obese women. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20090822002365N23. Registered on 16 August 2019.

Randomized Study of the Effect of Vitamin D and Omega-3 Fatty Acids Cosupplementation as Adjuvant Chemotherapy on Inflammation and Nutritional Status in Colorectal Cancer Patients.

This study aimed to evaluate the effects of vitamin D3 and omega-3 fatty acids cosupplementation on inflammation and nutritional status in colorectal cancer patients. In this clinical trial, 81 colorectal cancer patients were randomly assigned into four groups: (1) control group: receiving a vitamin D3 placebo weekly + omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids) daily + a vitamin D3 placebo weekly; (3) vitamin D group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acids capsules daily for 8 weeks. Before and after the intervention, height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin, were measured. After 8 weeks of intervention, patients who received combined vitamin D3 and omega-3 fatty acids supplements compared with omega-3, vitamin D3, and placebo groups had significantly decreased CRP and TNF-α. In addition, serum level of IL-6 was decreased significantly in omega-3, vitamin D3, and cosupplementation groups compared with baseline. Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D3, omega-3, and cosupplementation groups at the end of the intervention. Vitamin D3 plus omega-3 fatty acids cosupplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer: a study protocol for a double blind randomized controlled trial.

BACKGROUND: Much evidence is available demonstrating that both vitamin D and omega-3 fatty acids block the development and progression of colonic carcinogenesis. The results of animal studies have shown that the consumption of omega-3 fatty acids can decrease inflammatory biomarkers, enhance the efficacy of chemotherapy, and decrease the side effects of chemotherapy or cancer. Also, observational studies propose that higher levels of 25(OH)D are related to improved survival of colorectal cancer patients. This study will aim to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in colorectal cancer patients. METHODS/DESIGN: We will carry out an 8-week double-blind randomized, placebo-controlled clinical trial to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with stage ӀӀ or ӀӀӀ colorectal cancer undergoing chemotherapy. DISCUSSION: Because of the important effects of vitamin D and omega-3 fatty acids on molecular pathways involved in cancer development and progression, it seems that both vitamin D and omega-3 fatty acids may provide a new adjuvant therapy by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with colorectal cancer. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180306038979N1. Registered on 16 March 2018.

Comparing the effectiveness of vitamin D plus iron vs vitamin D on depression scores in anemic females: Randomized triple-masked trial.

Background: Low levels of 25-hydroxyvitamin D (25(OH)D) have been related to depression and anxiety. It seems that anemia is associated with vitamin D deficiency. We aimed to evaluate the effects of iron-vitamin D co-supplementation versus vitamin D alone on depression scores in anemic females with low levels of serum 25-hydroxyvitamin D. Methods: This randomized controlled trial was conducted on eighty premenopausal females who were recruited between May 2015 and October 2015 from primary health care centers. Women with anemia and low concentrations of 25(OH)D were randomized to either 1000 IU/d vitamin D plus 27 mg/d iron (D-Fe) or vitamin D plus placebo supplements (D-P) for 12 weeks. Depressive and anxious symptoms were evaluated with the Beck Depression Inventory (BDI) with subscales 1-13 and 14-21 and Beck Anxiety Inventory (BAI). To compare the groups, Mann-Whitney or chi-squared tests were used and within groups comparison was performed using Wilcoxon signed ranks test. The study was registered on www.clinicaltrial.org as NC 01876563. Results: The serum concentrations of 25(OH)D were increased significantly in both groups at the end of the study. In both groups, there was a significant improvement in total BDI, the BDI subscale, and the BAI scores (p<0.001). No differences were found between groups (p>0.05). Conclusion: Although the potential positive effect of vitamin D on mental health was evident, iron plus vitamin D co-supplementation did not demonstrate any significant benefits over vitamin D alone, neither in depression score reduction nor anxiety symptoms.