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The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Renal Transplant Recipients
FAVORIT "high dose" multivitamin, FAVORIT "low dose" multivitamin
University of Alabama at Birmingham School of Medicine
Active, not recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Published on BioPortfolio: 2014-08-27T03:55:06-0400
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to pat...
This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a ...
The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This...
In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life...
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol
Vitamin and mineral deficiencies are common following Roux-en-Y gastric bypass (RYGB) and can lead to significant morbidity, but little research on the efficacy of vitamin supplementation regimens exi...
Essential for drug dose adjustment is the glomerular filtration rate (GFR) not the serum creatinine level. In acute disease, a loading dose must be given that usually corresponds to the normal dose. ...
This chapter focuses on the definitions and impact of prescription and delivery of the right dose of treatment in patients on continuous renal replacement therapy (CRRT). We define "dose" and the conc...
Liver transplant recipients (LTR) who are seropositive for cytomegalovirus (CMV) (R+) are at intermediate-risk for CMV disease. A preventive strategy following transplant is considered standard of car...
High-dose interleukin-2 (HD IL-2) is used in the treatment of metastatic renal cell carcinoma (mRCC) and has an overall response rate (ORR) of 12-20% and a complete response rate (CR) of 8% in unselec...
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...