Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of Gastroesophageal Reflux Disease Symptoms: A Clinical Trial.

BACKGROUND/AIMS: Proton pump inhibitors are frequently used to treat gastroesophageal reflux disease, but their effect is restricted. The present study aimed to investigate whether the addition of sublingual melatonin to omeprazole was effective in the treatment of gastro gastroesophageal reflux disease symptoms. MATERIALS AND METHODS: This was a randomized double-blind clinical trial. A total of 78 patients with gastro gastroesophageal reflux disease were randomly allocated to either omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) or omeprazole 20 mg/d plus placebo for 4 weeks. The selected patients had histories of heartburn and regurgitation and a score ≤32 on the Frequency Scale for the Symptoms of gastroesophageal reflux disease (FSSG). The outcome measures for the assessment of treatment efficacy were heartburn, epigastric pain and the Frequency Scale for the Symptoms of gastroesophageal reflux disease score. Safety and quality of life were evaluated in the patients as the secondary outcomes too. RESULTS: Seventy-two out of 78 eligible patients completed this trial (35 in the melatonin group and 37 in the placebo group). Heartburn, epigastric pain, and Frequency Scale for the Symptoms of gastroesophageal reflux disease score declined significantly in the melatonin group compared to the placebo group (P = .04, P = .03, and P = .0001, respectively). Moreover, the quality of life score was significantly higher in the melatonin group compared with the placebo group (P = .0001). Adverse events were similarly observed in the 2 groups (P = .55), and there were no serious adverse events. CONCLUSION: The combination of sublingual melatonin (3 mg/day) with omeprazole (20 mg/day) may be more effective than omeprazole (20 mg/day) alone in the treatment of gastroesophageal reflux disease.

Effect of folic acid on the sexual function of postmenopausal women: a triple-blind randomized controlled trial.

BACKGROUND: There are reports of sexual dysfunction in postmenopausal women, and several treatment recommendations are available. AIM: To investigate the effect of folic acid on postmenopausal women's sexual function. METHODS: This triple-blind randomized controlled trial was conducted in Tehran, Iran, in 2020. A sample of 100 postmenopausal women was recruited from comprehensive health centers affiliated with the Shahid Beheshti University of Medical Sciences. Eligible women were randomly assigned to receive folic acid (5 mg) or placebo on an empty stomach every day for 8 weeks. Women were assessed at 3 time points: baseline and 4 and 8 weeks after the intervention. OUTCOME: Sexual function was the main outcome, as measured by the Female Sexual Function Index. RESULTS: The mean ± SD age of participants in the folic acid and placebo groups was 53.2 ± 3.84 and 54.4 ± 4.05 years, respectively (P = .609). The results obtained from mixed effects analysis of variance revealed a statistically significant difference between baseline and posttreatment scores and the interaction between time and group for desire, orgasm, satisfaction, arousal, pain, and total sexual function score, with the folic acid group improving more than control group. Lubrication was the only domain that showed no significant difference for the interaction between time and group. CLINICAL IMPLICATIONS: Folic acid may beneficially affect sexual function in postmenopausal women. STRENGTHS AND LIMITATIONS: Strengths include the novelty of the subject, the triple-blind design, the block randomization, the administration of a standard scale for sexual function (Female Sexual Function Index), and the affordability and availability of folic acid. This study was conducted with a small sample size and short follow-up time; therefore, interpretation of the results requires great caution. CONCLUSION: The findings suggest that folic acid possibly improves sexual function in postmenopausal women. Larger studies are needed to confirm the findings. TRIAL REGISTRATION: IRCT20150128020854N8; August 2, 2020. Iranian Registry of Clinical Trials; https://en.irct.ir/user/trial/48920/view.

Role of vitamin C and rectal indomethacin in preventing and alleviating post-endoscopic retrograde cholangiopancreatography pancreatitis: a clinical study.

BACKGROUND/AIMS: This study aimed to determine whether vitamin C in addition to indomethacin decreases the occurrence and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurrence and severity. METHODS: This randomized clinical trial included patients undergoing ERCP. The participants were administered either rectal indomethacin (100 mg) plus an injection of vitamin C (500 mg) or rectal indomethacin (100 mg) alone just before ERCP. The primary outcomes were PEP occurrence and severity. The secondary amylase and lipase levels were determined after 24 hours. RESULTS: A total of 344 patients completed the study. Based on intention-to-treat analysis, the PEP rates were 9.9% for indomethacin plus vitamin C plus indomethacin and 15.7% for indomethacin alone. Regarding the per-protocol analysis, the PEP rates were 9.7% and 15.7% in the combination and indomethacin arms, respectively. There was a remarkable difference between the two arms in PEP occurrence and severity on intention-to-treat and per-protocol analyses (p=0.034 and p=0.031, respectively). The post-ERCP lipase and amylase concentrations were lower in the combination arm than in the indomethacin alone arm (p=0.034 and p=0.029, respectively). CONCLUSION: Vitamin C injection in addition to rectal indomethacin reduced PEP occurrence and severity.

Endocannabinoids and related compounds as modulators of angiogenesis: Concepts and clinical significance.

Vasculogenesis (the process of differentiation of angioblasts toward endothelial cells and de novo formation of crude vascular networks) and angiogenesis (the process of harmonized sprouting and dispersal of new capillaries from previously existing ones) are two fundamentally complementary processes, obligatory for maintaining physiological functioning of vascular system. In clinical practice, however, the later one is of more importance as it guarantees correct embryonic nourishment, accelerates wound healing processes, prevents uncontrolled cell growth and tumorigenesis, contributes in supplying nutritional demand following occlusion of coronary vessels and is in direct relation with development of diabetic retinopathy. Hence, discovery of novel molecules capable of modulating angiogenic events are of great clinical importance. Recent studies have demonstrated multiple angio-regulatory activities for endocannabinoid system modulators and endocannabinoid-like molecules, as well as their metabolizing enzymes. Hence, in present article, we reviewed the regulatory roles of these molecules on angiogenesis and described molecular mechanisms underlying them.

Drug-induced esophagitis and helpful management for healthcare providers.

In recent decades, the number of cases developing drug-induced esophagitis (DIE) has reportedly been growing, which indicates the significance of detecting medicines capable of causing this adverse reaction. This study aims to provide an updated review on recent case reports of DIE, to evaluate the possible mechanism of this side effect, and to provide helpful management. Data was gathered through searches of three databases, namely PubMed, Medline, and Cochrane. Seven drug categories were evaluated: antibiotics, bisphosphonates, cardiovascular medicines, chemotherapeutic agents, non-steroidal anti-inflammatory drugs (NSAIDs), other medications, and supplements. According to the findings, retrosternal pain, heartburn, odynophagia, and dysphagia are typical symptoms of DIE, and in most cases, DIE is a self-limiting side effect which can be resolved by removing the causative agent and providing supportive therapy.

A Comprehensive Review of the Role of Complementary and Dietary Medicines in Eradicating Helicobacter pylori.

Antibiotic-resistant Helicobacter pylori isolates have become a global concern. The standard triple or quadruple therapies have recently become the most effective protocol for eradicating H. pylori in the gastrointestinal tract. There is evidence regarding the impact of different complementary or dietary supplements on H. pylori eradication. This review article intended to search electronic bibliographic databases for any clinical studies that evaluated the use of any herbal or dietary supplements to eradicate H. pylori up to June 2021. A total of 20 human studies met our criteria and were reviewed. Although some herbal medicines have shown their efficacy and safety in eradicating H. pylori in different clinical trials, more randomized blind, placebo-controlled human trials with a large sample size must be performed to extend our knowledge.

Case report: Bilateral simple Syndactyly in a toddler with maternal exposure to cabergoline.

Cabergoline is routinely prescribed in the management of prolactin excreting adenomas and is associated with low risk of congenital malformations and teratogenicity. Here, we reported the case of a bilateral simple syndactyly in a toddler with maternal exposure to cabergoline during the pregnancy. This association has not been previously described before.

A Phase I Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety Profile of a Sublingually Administered Cannabidiol /Delta 9-tetrahydrocannabidiol (10: 1) Regimen in Diabetes Type 2 Patients.

The current study aimed to evaluate the safety profile and efficacy of a cannabis-based sublingual spray, CBDEX10® (containing 100 µg cannabidiol and 10 µg Δ9-tetrahydrocannabinol per puff; CBD/Δ9-THC 10:1), in improving lipid profile and glycemic state of the diabetic patients. Fifty diabetic patients were randomly allocated to the treatment (n = 25; receiving two puffs of CBDEX10® twice daily) or the control groups (n = 25; receiving two puffs of placebo). The primary endpoint of the study was to evaluate the efficacy of the CBDEX10® adjunctive therapy in improving the lipid profile and glycemic state of diabetic patients; the secondary endpoint was to assess the safety profile and tolerability of the spray. A statistically significant decline in total cholesterol [estimated treatment difference (ETD) = -19.73 mg/dL; P < 0.05], triglyceride (ETD = -27.84 mg/dL; P < 0.01), LDL-C (ETD = -5.37 mg/dL; P < 0.01), FBS (ETD = -12 mg/dL; P < 0.01), Hb A1C (ETD = -0.21 mg/dL; P < 0.01) and insulin secretion (ETD = -5.21 mIU/L; P < 0.01) was observable in the patients treated with CBDEX10® at the end of the 8-week treatment period. Regarding safety, the mentioned adjunctive regimen was well, and there were no serious or severe adverse effects. Overall, CBDEX1® sublingual spray could be a new therapeutic agent for lipid and glycemic control in diabetic patients.

Benefits and Risks of Melatonin in Hepatic and Pancreatic Disorders; A Review of Clinical Evidences.

Melatonin is the "clock factor" produced from the pineal gland dominating regular circadian rhythm in mammalians. It is an indoleamine with potent multifunctional pharmacological effects, both receptor dependent and non-receptor dependent effects, including antioxidant and anti-inflammatory activities. The aim of this review is to summarize clinical evidence related to melatonin's effectiveness in the treatment of liver and pancreas diseases. Databases including PubMed, Scopus, and Cochran Library were searched up to November 2020.Finally, this review has summarized up-to-date clinical evidence to investigate the efficacy and safety of melatonin for the management of liver and pancreas diseases. Melatonin has been demonstrated to have beneficial effects on the management of Non-alcoholic fatty liver disease (NAFLD), sleep disturbance of cirrhotic patients, prevention of drug/poison induced liver toxicity,and prevention of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP);more data is needed to recommend melatonin administration in the treatment of mentioned disorders.

Efficacy and Safety of Melatonin as an Adjunctive Therapy on Clinical, Biochemical, and Quality of Life in Patients with Ulcerative Colitis.

Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The exact etiology of UC is unknown, but the role of autoimmunity and activated inflammatory cascade is quite clear. Melatonin possesses anti-inflammatory and immune-modulative properties in animal and clinical trials. The aim of the present study was to evaluate the efficacy and safety of oral melatonin as an adjudicative therapy in clinical, biochemical, and quality of life in UC patients. Thirty patients diagnosed with mild to moderate UC, were randomly allocated to either receive melatonin (3 mg/d) or the placebo group for three months. Simple clinical colitis activity index (SCCAI), fecal calprotectin (FC), C-reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Sf-36 questionnaire have been used for assessment at the baseline and the end of the trial. Melatonin significantly improve SCCAI score, FC, role-emotional, energy and general health relative to placebo (p = 0.03, 0.05, 0.002, 0.032, 0.004 respectively). Regarding CRP, ESR, and the other components of SF-36 there is not any significant difference between melatonin and placebo group. Melatonin supplementation over a three-month period is effective and safe in improving clinical index, FC, and some quality of life in patients with mild to moderate UC.

Efficacy and safety of propolis mouthwash in management of radiotherapy induced oral mucositis; A randomized, double blind clinical trial.

AIM AND BACKGROUND: Propolis has been used for the management of oral mucositis in a number of studies. Due to lack of sufficient evidence especially in radiotherapy induced oral mucositis, the present study was designed to evaluate the efficacy and safety of propolis mouthwash in oral mucositis and dysphagia in patients undergoing head and neck radiotherapy. MATERIALS AND METHODS: This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients randomly divided into two groups receiving either the propolis or the placebo mouthwash. Patients were advised to rinse their mouth with 15 mL three times daily for four weeks. Severity of mucositis and dysphagia were evaluated by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and Common Terminology Criteria for Adverse Events (CTCAE), respectively. RESULTS: Thirty patients completed the study. Each group consisted of 15 patients. Although, there is not any significant difference between two groups in the first week of radiotherapy, a significant difference was seen in the second, the third and the fourth week (p = 0.03, 0.02, 0.02, respectively). Dysphagia reported as a mild score in the propolis group only in the fourth week which is significant compared with the placebo group (p = 0.01). There is not any serious adverse effect related to propolis or placebo during the study. CONCLUSION: It seems that propolis mouthwash is an effective and safe medication for alleviation of oral mucositis and dysphagia in patients under head and neck radiotherapy.

Glutamine powder-induced hepatotoxicity: it is time to understand the side effects of sports nutritional supplements.

Glutamine has been considered as a dietary supplement with a non-essential amino acid structure. Some studies have found that liver failure may be associated with a high plasma glutamine level. Consumption of this product may be linked to potential adverse effects. This report describes the first case of glutamine-induced hepatotoxicity. A 35-year-old female athlete with severe abdominal pain and scleral icterus was referred to the hospital. She had been taking glutamine powder for the past three weeks. Impaired liver function test and imaging evaluation suggested hepatotoxicity. Glutamine consumption was discontinued and the patient was closely monitored. Finally, after two weeks, the patient recovered successfully. This novel case was the first report regarding glutamine-induced hepatotoxicity. Health care providers must know that consumption of dietary supplements such as glutamine may be associated with serious side effects. Liver damage is a possible side effect of glutamine. Hence it is necessary to consider hepatotoxicity as an adverse reaction in case of glutamine supplement consumption.

Comparison of the efficacy and safety of melatonin and memantine in the alleviation of cognitive impairments induced by electroconvulsive therapy: A randomized clinical trial.

The purpose of this study was to assess and compare the efficacy and safety of melatonin and memantine in the alleviation of cognitive disorders in patients diagnosed with major depressive disorder (MDD) undergoing electroconvulsive therapy (ECT). Patients undergoing ECT for treatment of MDD were randomly allocated to the melatonin (3 mg/d) or memantine (5 mg/d) groups. The participants received either melatonin or memantine (tablet) through the ECT therapy, which was started at beginning the first day of ECT and continued to the sixth session. The Modified Mental State Examination (MMSE) was used to evaluate cognitive function before and after the intervention. Frothy eligible patients (22 females and 18 males) were studied. There was no significant difference between two groups in terms of demographic characteristics, hemodynamic parameters and baseline MMSE and item 3 MMSE. The Memantine group scored significantly higher at the end of the ECT sessions either by MMSE or item 3MMSE than the baseline (P = 0.04 and P = 0.03, respectively). In the melatonin group, both MMSE and item 3MMSE scores were decreased significantly than the baseline (p = 0.03 and p = 0.02, respectively). No withdrawal was observed due to the drugs' adverse effects. It seems that memantine (5 mg/d) is more effective than melatonin (3 mg/d), to alleviate cognitive disorders induced by ECT.

Buccal Buspirone as add-on Therapy to Omeprazole Versus Omeprazole in Treatment of Gastroesophageal Reflux Diseases (GERD).

Proton pump inhibitors (PPIs) are recommended as first line treatments for gastroesophageal reflux disease (GERD). Failure to PPIs has been mentioned as a problem in pharmacotherapy of GERD. The present study compared the symptom relief, quality of life (QoL) and adverse drug reactions (ADRs) of omeprazole plus buccal buspirone with that of omeprazole alone.This was a prospective, randomized trial between buccal buspirone (10 mg/d) plus omeprazole (20 mg/d) and omeprazole (20 mg/d) plus placebo administered for 4 weeks to patients with GERD symptoms. Patients who had GERD symptoms enrolled in this study. 67 patients were randomly assigned to either the buspirone plus omeprazole group (n = 33) or the placebo plus omeprazole group (n = 34). Finally, 58 patients completed the study (29 in each group). Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG). The QoL and ADRs have been also evaluated too.The treatment score rates for symptom relief according to the FFSG were 7.13 ± 5.13 in the buspirone group and 15.34 ± 8.17 in the placebo group. Regarding FFSG score, there is a significant difference between the groups (p < 0.0001). QoL were 6.86 ± 6.65 and 27.2 ± 20.95 in placebo and buspirone group, respectively after four weeks and there is a significant difference in two groups ( p < 0.0001).The total incidence of ADRs were similar in the buspirone and placebo groups (p = 0.36).A combination of buccal buspirone plus omeprazole may be a more effective treatment for GERD than omeprazole alone.

Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial.

OBJECTIVE: Post-ERCP pancreatitis (PEP) is the most prevalent complication of endoscopic retrograde cholangiopancreatography (ERCP). Melatonin has been mentioned as a protective factor against acute pancreatitis. The present study was conducted to determine whether melatonin addition to indomethacin reduces the rate of PEP occurrence. METHODS: A double-blind randomized clinical trial was conducted on 411 patients undergoing ERCP. Baseline blood samples were collected, and the patients were given melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository 100 mg, 1 h before ERCP. The occurrence of PEP was the primary outcome. The concentrations of amylase and lipase were also measured 24 h after ERCP. RESULTS: Demographic characteristics of patients, characteristics of ERCP procedures, and baseline levels of amylase and lipase were found to be similar in both groups. The overall rate of PEP was equal to 9.5% in intention-to-treat (ITT) and 11.4% in per-protocol (PP) analyses. There was a significant difference in the rate of PEP between the melatonin and placebo groups (8.7% vs. 11.4% in ITT and 9.3% vs. 13.6% in PP, respectively). In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively). CONCLUSION: The results of the present study showed that, administration of melatonin 3 mg tablets plus indomethacin suppository 100 mg 1 h before ERCP could decrease the PEP rate and amylase and lipase levels compared to administration of indomethacin suppository 100 mg alone.

Effect of Bedtime Melatonin Administration in Patients with Type 2 Diabetes: A Triple-Blind, Placebo-Controlled, Randomized Trial.

Melatonin is widely available as over the counter product. Despite promising effects of melatonin supplementation on glycemic control, there is a significant heterogeneity between studies. The current study aimed at determining the effect of melatonin on fasting blood glucose (FBG), insulin resistance/sensitivity indices, glycosylated hemoglobin A1c (HbA1c), and high sensitivity C-reactive protein (hs-CRP) among type 2 diabetes mellitus (T2D) population during 8 weeks in a randomized, triple-blind, placebo-controlled trial. Thirty four subjects with the mean age ± standard deviation of 57.74 ± 8.57 years and 36 subjects with the mean age of 57.61 ± 9.11 years were allocated to 6 mg nightly melatonin and placebo groups, respectively. Melatonin and placebo groups were matched by age, gender, body mass index, and duration of diabetes. Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%, P=0.042). After trial completion, the increase of serum levels of melatonin was greater in the intervention than the placebo group (3.38 ± 1.33 vs 0.94 ± 1.28 ng/L, P=0.192). Moreover, compared to placebo group, among melatonin users, homeostasis model assessment of insulin resistance (HOMA1-IR) tended to be unfavorable at the end of follow-up [-0.51 (-1.76-0.81) vs. 0.28 (-1.24-1.74), P=0.20]; the similar trend was also shown for insulin sensitivity index (HOMA1-S) [2.33 (-3.59-12.46) vs. -2.33 (-10.61-9.16), P=0.148]. No differences were observed in FBG, HbA1C, and hs-CRP changes between the trial groups. The current study did not support the improving effect of melatonin on glucose homeostasis.

Epinephrine in the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Preliminary Study.

BACKGROUND: Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) ranges between 15 and 20% among patients at high risk of developing PEP. The efficacy of indomethacin administration in the prevention of PEP is rather debatable. In the present randomized trial study, we evaluated whether or not the combination of indomethacin and epinephrine in comparison to the single administration of indomethacin differs in the pathogenesis and prevention of post-ERCP pancreatitis. PATIENTS AND METHODS: One hundred and ninety-two patients were randomized in a double-blinded manner into 3 groups: the epinephrine group (group A), the indomethacin group (group B), and the combined epinephrine and indomethacin group (group C). After the procedure, patients were evaluated for the PEP development. RESULTS: During the procedure, 66 patients were randomized to the epinephrine group (group A), 68 cases to the indomethacin group (group B), and 58 individuals to the indomethacin-epinephrine group (group C). The mean age of patients in the epinephrine group was 59.59 ± 15.680 years, in the indomethacin group it was 58.06 ± 17.125 years, and in the combination group it was 59.62 ± 15.369 years. In the present study, we did not observe a significant difference between the 3 groups in sex, age, pre-ERCP amylase, lipase, and patient and procedure risk factors including pancreatic duct (PD) dilation (p = 0.404), PD cannulation (p = 0.329), and difficult cannulation (p = 0.076) among others. PEP developed in 7 of the 192 individuals (3.6%), 6 PEP cases occurred in the indomethacin group and 1 in the epinephrine group (p = 0.016). Univariate analysis of risk factors for PEP in patients with and without pancreatitis revealed no significant difference between the pancreatitis group and the non-pancreatitis group. CONCLUSION: In comparison to the administration of indomethacin alone, a single application of epinephrine and the combination of epinephrine and indomethacin seem to be effective in reducing the cases of PEP. A further randomized clinical trial with a larger sample size is required to confirm the efficacy of our medication in the prevention of pancreatitis after ERCP.

Plasma Oxytocin Level and Sexual Dysfunction in Depressed Women Treated by Either Fluoxetine or Citalopram: a Pilot Clinical Trial.

Sexual dysfunction is a common cause of selective serotonin reuptake inhibitor (SSRI) withdrawal. Various studies indicate that decreased oxytocin is involved as a mechanism of delayed ejaculation induced by SSRIs. The aim of the present pilot study was to evaluate and compare sexual dysfunction and oxytocin levels in women being treated with either fluoxetine or citalopram. Thirty-nine women with the diagnosis of major depressive disorder were enrolled in the study. A baseline blood sample was collected and each participant was given either fluoxetine 20 mg/d or citalopram 20 mg/d. After 1 month, a second blood sample was collected and sexual dysfunction was evaluated via the Female Sexual Function Index (FSFI) questionnaire. Twenty-three women completed the study (12 and 11 in the fluoxetine and citalopram groups, respectively). After 1 month, the FSFI scores were 22.8 ± 7.8 and 22.5 ± 4.8 in the fluoxetine and citalopram groups, respectively. The oxytocin levels were 187.8 ± 38.8 pg/mL and 214.6 ± 23.1 pg/mL in the fluoxetine and citalopram groups, respectively. Statistical analysis did not reveal any difference in the FSFI score between the two groups after 1 month (p = 0.89). However, the oxytocin levels were significantly lower in the fluoxetine group than in the citalopram group (p = 0.05). We also observed a positive relationship between the FSFI score and oxytocin level at 1 month after starting fluoxetine or citalopram (r = 0.43, p = 0.04).A positive relationship between the oxytocin level and FSFI score supports the hypothesis that the oxytocin level plays a role in sexual dysfunction induced by SSRIs.

Effects of Parenteral Vitamin D on the Biomarkers of the Endothelial Function in Patients with Type 2 Diabetes and Ischemic Heart Disease: A Randomized Clinical Trial.

Vitamin D deficiency is associated with cardiovascular and metabolic diseases. Cardiovascular diseases, in turn, are responsible for mortality of patients with type 2 diabetes (T2D). We investigated whether a single parenteral dose of 25(OH) Vit D could improve the endothelial function in T2D patients with ischemic heart disease. A randomized, placebo-controlled, and double-blind trial was performed on 112 patients randomly divided into vitamin D (n = 55) and placebo (n = 57) groups. A randomization table was used to administer a single dose of either vitamin D (300000 IU) or a matching placebo, intramuscularly. The levels of 25(OH) Vit D, intercellular adhesion molecule 1 (ICAM-1), and vascular cell adhesion molecule 1 (VCAM-1) were measured at baseline and at 8 weeks. In the supplemented group, the level of serum 25(OH) Vit D was increased significantly (29.6 ± 20.8 vs. 44.5 ± 19.2 ng/mL; P < 0.05), whereas no changes were observed in the placebo group. Within the supplemented group, before and after vitamin D intervention no significant changes in the levels of ICAM-1 and VCAM-1 were observed. The marginal means of the outcome variables (ICAM-1, VCAM-1, and 25(OH) Vit D) were compared between the groups using ANCOVA, adjusted for the baseline of each variable itself: no significant difference was seen in the markers of the endothelial function. A single parenteral dose of vitamin D in T2D patients with ischemic heart disease failed to show improvement in endothelial function.