221 Clinical Trials for Various Conditions
Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third post-operative day. Reduction of AF by various drugs is moderately effective, but involves either rate control with beta blockers or rate conversion with amiodarone after the myocardial damage processes initiating AF have already occurred. Decreasing the incidence of post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be more fruitfully approached by targeting the upstream combined processes of inflammation and coagulation activation induced by the surgical insult and associated ischemia-reperfusion (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be prevented and/or inhibited by antioxidant supplementation. Specifically the investigators hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and therefore damp down upstream inflammatory processes, leading to a reduction of downstream adverse events with demonstrable links to inflammation processes, such as AF.
Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However, the role of micronutrients, such as vitamins, on GH secretion has not been investigated in much detail. Vitamin C levels are also reduced in obesity, and the investigators recently demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion in two preliminary retrospective studies. The investigators therefore propose a more detailed prospective physiological study to examine the effects of increasing dietary vitamin C intake on GH secretion in a physiologic, intervention study. The investigators hypothesize that increasing vitamin C concentrations in obese subjects with sub-optimal plasma vitamin C levels and reduced GH secretion will increase GH secretion.
This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease. This study is funded by the FDA Office of Orphan Products Development (OOPD).
The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E supplements can help to prevent memory loss and dementia such as Alzheimer's disease.
Vitamin B12 is an essential nutrient that the body needs for cells to divide and function normally. Individuals may develop a deficiency of vitamin B12 by either limiting the amount in the diet or by decreased vitamin B12 intake into the body (absorption). Keeping adequate B12 blood levels is important for health. Vitamin B12 deficiency may increase one's risk for developing anemia and can even lead to neurological problems and paralysis if the deficiency is severe and lasts a long time. It is very important for doctors to have accurate tests to determine if people are absorbing vitamin B12 normally so that treatment can be started before severe clinical problems occur. The purpose of this research is to provide new information that may help scientists develop a better method to test for problems with absorbing vitamin B12. In this study, changes in the amounts of vitamin B12 bound to protein (transcobalamin) in the blood will be measured after doses of vitamin B12 are taken. If the amounts of this vitamin B12-protein complex (called holo-transcobalamin) change in response to taking a vitamin B12 supplement in normal individuals, it may be possible to use this information to develop a new sensitive test to identify individuals who have problems absorbing vitamin B12. This new vitamin B12 absorption test may be a better clinical test for vitamin B12 absorption than those now available for doctors to use.
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is called the autoantigen. Lupus can affect many parts of the body and often affects the skin, with immune cells attacking autoantigens in the skin and causing a rash. This rash is often visible to the public because it tends to occur on sun-exposed areas, for example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a source of disability and poor health related quality of life in many patients with this disease. It is not completely understood why or how someone might develop lupus, however there are likely many reasons which include their genetics and also the kind of environment they live in. One such environmental factor, vitamin D, is more commonly known as a vitamin important for bone health. However, we are learning that vitamin D has effects all over the body, and is also important for a healthy immune system. Low levels of vitamin D have been associated with an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and have also been found to be common in skin lupus patients. Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B radiation (UVB). The main source of vitamin D for most people is its production in the skin because the normal American diet is not high in vitamin D. However, patients with skin lupus tend to stay out of the sun because their rash is made worse by sunlight, which is thought to produce more of the autoantigens in the skin attacked by the immune system. Additionally, as skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize sun-sensitivity and prevent flares of their skin disease. However we may be putting them at risk for low vitamin D status and even more severe disease. Another risk factor that puts skin lupus patients at risk for vitamin D deficiency is that these patients generally have darker skin types which blocks UVB and further limits vitamin D production in the skin. Given that skin lupus patients are at high risk for low vitamin D status as mentioned above, the investigators propose a research study that will provide information about vitamin D levels in these patients. The investigators seek to identify how many skin lupus patients have low vitamin D status and how vitamin D influences the natural history of this skin disease. Additionally the investigators will evaluate whether or not supplementation with high dose vitamin D will lessen the severity and negative quality of life impact of skin lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over the counter method to replete and maintain a normal vitamin D status. Studies in other autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that high dose vitamin D supplementation improves disease severity. It is the hope of the investigators that this will also be observed in skin lupus patients. In summary, the investigators seek to move beyond establishing an association between vitamin D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any, of vitamin D status on disease severity and quality of life while controlling for important factors that may influence vitamin D status. If the investigators are to show improvement in disease severity with vitamin D supplementation, this would be a cost-effective additional therapy to our standard clinical practice. Future research would also allow us to investigate other alternative markers of vitamin D deficiency and disease activity in skin lupus patients, a population at high risk for low vitamin D status and in need of further research.
A genomics-based approach will target specific genes that may explain the response in biomarkers and symptoms before and after supplementation. One objective is to generate evidence-based recommendations for vitamin D supplementation in Soldiers who often experience musculoskeletal disorders and immune dysfunction impacting physical performance and military readiness. The investigation is designed to address these specific aims: 1) explore vitamin D status in 105 Service Members to determine common symptoms associated with deficiency; 2) examine the effect of vitamin D levels on gene expression from select genes known to influence metabolism, bone density, and immune function; and 3) evaluate changes in gene expression between groups receiving high or low supplementation, and compare to healthy controls. Follow-up at 15 months will evaluate circulating vitamin D.
The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.
Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.
The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD). This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.
The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.
This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems. The investigators hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Evaluation of the metabolic and physiological characteristics of patients with diagnosed Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.
A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.
This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4 patients will be eligible for participation if they have been determined to have vitamin D deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign an informed consent form after reviewing the protocol in detail with the principal investigator. A questionnaire would collect information about dietary vitamin D intake, sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12 pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a week. They would be scheduled to return to the clinic after 6 weeks and blood measurements would be repeated. Subjects will be asked to revisit for their final visit at the 12th week when they would have their last blood draw and assessment.
The purpose of this study is to determine whether reduction of homocysteine levels with high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimer's disease.
This study will look at the impact of ascorbic acid (Vitamin C) on the progression of disease in people with CMT1A as compared to volunteers receiving a placebo. This study will assess whether is it futile to proceed with a larger, longer-term, placebo-controlled study.
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
Hypothesis: 25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching 25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.
Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There may be many different reasons for the pruritis. Efforts to treat the problem have not been very effective. Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients. The objective of the investigators study is to determine the effect of supplementation with oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.
The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.
The relationship of Vitamin D levels in children and young adults to atherosclerosis.
Vitamin D deficiency (VDD) is very common among African American adolescents and adults in the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle weakness. The investigators believe VDD may contribute to poor musculoskeletal health and chronic pain seen in pediatric SCD. In this study, the investigators aim to show that children and adolescents with SCD and chronic pain have lower levels of vitamin D compared to those without chronic pain. The investigators also aim to determine the clinical characteristics in SCD patients related to their vitamin D status. About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain and 30 without chronic pain. The investigators will assess baseline characteristics including vitamin D levels, bone turnover rates (measured by C telopeptide blood levels \[CTx\]), markers of inflammation and oxidative stress levels in blood, baseline hemoglobin and other laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary function, opioid analgesic use, overall muscle strength, quality of life and depression. To evaluate the impact of vitamin D replacement on these baseline characteristics, the investigators will randomize subjects to receive either placebo or high dose vitamin D for 6 weeks after which time the investigators will evaluate overall vitamin D status, muscle and bone health, depression, quality of life, pain status and use of opioid pain medications, inflammation and oxidative status comparing before and after treatment with high dose vitamin D. The investigators will give-at no cost to subjects-a daily supplement that will provide the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium and 200IU vitamin D to subjects throughout the study period. Subjects will be in the study for 7 months and have five to six study visits.
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each taken by mouth once daily for a study duration of one year. Study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney disease and cardiovascular risk.