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The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

2011年7月28日 更新者:Tehran University of Medical Sciences

The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals

In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group.

研究概览

地位

未知

条件

详细说明

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 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 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.

研究类型

介入性

注册 (实际的)

84

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tehran、伊朗伊斯兰共和国
        • Tehran University of Medical Sciences, School of Public Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 52年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

waist to hip ratio >0.8 and BMI>30 kg/m2 for obese individuals waist to hip ratio <0.8 and BMI 18.5 - 24.9 kg/m2 for Non obese individuals

Exclusion Criteria:

  • subjects who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
  • subjects with pregnancy, lactation, menopause, diabetes
  • subjects who have allergy to vitamin A compounds, OR
  • subjects who have used vitamin supplements or in last 3 months, OR
  • subjects with morbid obesity(BMI >40 kg/m2),OR
  • overweight subjects (25 <BMI<29.9 kg/m2)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Non obese/ vitamin A
Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

安慰剂比较:obese/ placebo
obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

有源比较器:Obese/ vitamin A
obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Complete Blood Count-diff
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum HDL concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum LDL concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum total cholesterol concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum Triglycerides concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum SGOT concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum SGPT concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum T3 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum T4 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum TSH concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum FBS concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum CRP concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum RF concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months

次要结果测量

结果测量
大体时间
Serum IL-2 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-6 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-10 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-12 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-13 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-17 concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Seum IL-1β concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
Serum TGF β concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
serum IFN γ concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months
serum Angiotensin П concentrations
大体时间:Change from baseline at 4 months
Change from baseline at 4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年2月1日

初级完成 (预期的)

2013年2月1日

研究完成 (预期的)

2013年8月1日

研究注册日期

首次提交

2011年2月14日

首先提交符合 QC 标准的

2011年7月28日

首次发布 (估计)

2011年7月29日

研究记录更新

最后更新发布 (估计)

2011年7月29日

上次提交的符合 QC 标准的更新

2011年7月28日

最后验证

2011年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 89-04-27-11869

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Vitamin A的临床试验

3
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