Immunomodulating Effects of Supplementation With 25 oh Vitamin D in Adults With Scleroderma and Hypovitaminosis D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Effects of vitamin D supplementation on the Th1, Th2 and Treg cytokine profile in adults with scleroderma and hypovitaminosis D
研究概览
简要总结
Introduction. The thickening fibrotic of the skin in systemic sclerosis (SSc) could reduce endogenous availability of Vitamin D by sun exposition. Vitamin D hypovitaminosis have been described in high prevalence in autoimmune disease as SSc. The cholecalciferol contributes to improve the balance TH1/Th2/Treg in favor anti-inflammation and anti-fibrotic profile.
Aim. to analyze the effect(s) of short-term cholecalciferol supplementation on cytokine profile in Th1, Th2, and Treg cells subpopulations in SSc patients.
Method. Randomized clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. General characteristics, severity of organ involvement scored by Medsger disease severity scale (MsDSS) and cytokine Th1, Th2 and Treg will be determinate.
All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.
详细描述
The study will be carried out with prior authorization from the Local Research and Ethics Committee. Patients entitled to our healthcare services and complying with screening criteria will be included.
Patients with scleroderma included in our database will be invited to participate in the study through a telephone call. Patients complying with the screening criteria and accepting to participate in the study will be given a date.
On the day of the interview, they will be given the informed consent form. Once it has been signed, they will be asked to complete clinical recorder and serum samples were collected for biochemical determinations including Vitamin D status.
Once patients have completed the initial evaluations, another visit will be scheduled two weeks later. Patients with hypovitaminosis D result will be randomly assigned to one of two groups: Group 1. Vitamin D3 supplementation and Group 2. Dietary recommendations. Two groups given instructions to follow dietary recommendations or to receive vitamin D3 supplementation and complete the medical measurements. Additionally, the investigators included SSc patients with vitamin D sufficiency and another one with healthy donors.
On the second visit (four weeks later), clinical data and the following parameters will be recorded: calcium, phosforus, parathyroid hormone by quimioluniscencia 25-hydroxyvitamin D serum status by ELISA, intracellular cytokine (IL-2, INF-γ, IL-4 and IL-10) production from Th1, Th2 and Treg lymphocytes by flow cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The MD who processed the data and molecular proceedings unknown the intervention in each individual.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scleroderma individuals according to 2013 American College of Rheumatology/European League against Rheumatism (ACR/EULAR 2013) classification criteria for SSc.
排除标准
- •insufficient data to enable classification
- •any acute bacterial infection
- •abnormal kidney function
- •comorbidity
- •other chronic disease degenerative disease such as diabetes and malignancies
- •subjects who received biological therapy or mycophenolate-mofetil during the previous month.
结局指标
主要结局
Effects of vitamin D supplementation on the Th1, Th2 and Treg cytokine profile in adults with scleroderma and hypovitaminosis D
时间窗: 2 years
To assess whether vitamin D3 supplementation modifies the proportion of cytokines inTh1 (IL-2 (%) / INF-ү (%)), Th2 (IL-4 (%)), Treg (IL-10 (%)) cells, in patients with scleroderma and hypovitaminosis D, by flow cytometry.
次要结局
- Association between vitamin D, Th1 (IL-2 / INF-γ), Th2 (IL-4), and Treg (IL-10).(2 years)
- Vitamin D and cirokines serum levels in scleroderma patients with hypovitaminosis D(2 years)
- Clinical effects of vitamin D3 supplementation in patients with scleroderma and hypovitaminosis D.(two months from the recruitment of each individual)
研究者
Maria del Pilar Cruz Dominguez
Chief of Research Division
Coordinación de Investigación en Salud, Mexico