Ignite Creation Date:
2024-05-05 @ 9:47 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00963222
Status:
UNKNOWN
Last Update Posted:
2012-06-05
First Post:
2009-08-20
Brief Title:
The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1Th2 Balance in Patients With Atherosclerosis
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Th1Th2 balance in patients with and without atherosclerosis documented with angiography
Detailed 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 Th1Th2 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 Th1Th2 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 mechanisms 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 IFNγ production and increases IL4 production in antigen primed CD4 T cells Supplemental treatment with vitamin A or retinoic acid RA decreases IFNγ 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None