Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01405352
Status:
UNKNOWN
Last Update Posted:
2011-07-29
First Post:
2011-02-14
Brief Title:
The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
The Effect of Vitamin A Supplementation on CD4 T-cell Secretion in Obese Individuals
Status:
UNKNOWN
Status Verified Date:
2011-07
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:
In this double blind placebo controlled trialcytokine secretion of CD4 T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group
Detailed Description:
Obesity is a chronic disease consisting of the increase in body fat stores Obesity is an important health concern because of its well known relationships with metabolic and endocrine disorders such as cardiovascular disease type 2 diabetes hypertension and immune dysfunction Low-grade systemic inflammation confirmed by the increase of inflammatory markers such as C-reactive protein and interleukin-6 has been observed in obesity CD4 T-helpers are the most important regulators of immune system Epidemiological evidence has linked obesity to several but not all autoimmune disorders including inflammatory bowel disease IBD and psoriasis Some sublineages of T- helpers plays core roles in immune dysfunction and recent evidence demonstrates that an imbalance of T-cell subgroups including Th1 Th2 Th17 and Treg has occurred in obesity This imbalance is the redirection of the immune response from most often Th2 and Treg like responses to Th1 and Th17 like responses respectively however the opposite is desired 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 and TNF α 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
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