Home | All trials

[RDF data]
Trial NCT00963222

Resource URI: http://static.linkedct.org/resource/trials/NCT00963222
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/64964>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/64965>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/64975>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/64976>
linkedct:brief_title The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis
linkedct:condition <http://static.linkedct.org/resource/condition/1288>
linkedct:criteria Inclusion Criteria: - The criteria for enrollment of the patients and control subjects is consecutive patients of both sexes referred to the Division of Cardiology of the one of the Hospitals of Tehran University of Medical Sciences for coronary angiography for investigation of chest pain and/or suspected CAD. Exclusion Criteria: - Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR - Patients who have allergy to vitamin A compounds, OR - Patients who have used vitamin supplements in last 3 months.
linkedct:description Atherosclerosis, the leading cause of death and disability in the world, is considered an inflammatory disease with a complex etiology. The immune system has a prominent role in the formation, development and destabilization of atherosclerotic plaques. A whole range of identified cytokines have been shown to play a part in atherogenesis, some with proatherogenic properties while others having antiatherogenic properties. With increasing evidence for the significant role of inflammation and the cytokines involved together with the Th1/Th2 imbalance in atherosclerosis and its progression to Coronary artery diseases (CADs), the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFN production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFN and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 60 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:end_date March 2011
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date August 20, 2009
linkedct:has_dmc Yes
linkedct:id NCT00963222
linkedct:intervention <http://static.linkedct.org/resource/intervention/101919>
linkedct:intervention <http://static.linkedct.org/resource/intervention/120054>
rdfs:label Trial NCT00963222
linkedct:lastchanged_date September 9, 2009
linkedct:lead_sponsor_agency Tehran University of Medical Sciences
linkedct:location <http://static.linkedct.org/resource/location/327444>
linkedct:nct_id NCT00963222
linkedct:number_of_arms 4 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Atherosclerosis
linkedct:org_study_id 86-04-27-6617
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1555>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/17716>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39292>
linkedct:overall_status Enrolling by invitation
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00963222>
linkedct:phase Phase 4
linkedct:primary_completion_date September 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/64196>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/64197>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/60482>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/95256>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99172>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99214>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99247>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99269>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99271>
linkedct:source Tehran University of Medical Sciences
linkedct:start_date September 2009
linkedct:study_design Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 3 months on immune system and Th1/Th2 balance in patients with and without atherosclerosis (documented with angiography).
rdf:type linkedct:trials
linkedct:verification_date September 2009