Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FIBROMYALGIA IMPACT QUESTIONNAIRE
研究概览
简要总结
Fibromyalgia is a disease that significantly decreases the quality of life of people who suffer from it, has great repercussions at the socio-economic level due to the incapacity it produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological stress and mental alterations, besides presenting painful points in different parts of the body to physical examination. Having few effective treatments is necessary to explore new options in their management to improve the general conditions of the patient. Previous studies have shown that patients with fibromyalgia have had low levels of vitamin D in the blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin has been associated with pain pathways and with increased The perception of the same when it is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external consultation of Rheumatology of the University Hospital "Dr. José Eleuterio González "of the UANL, over 18 years old who have not been previously supplemented with vitamin D, will initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we will have a group that will only receive placebo and Another that will be supplemented with 50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale and another one that measures the impact of the disease in the daily life of the patient, this will be done in a beginning and at the end of the 12 weeks .
详细描述
Fibromyalgia is a disease characterized mainly by generalized pain, with great repercussion in the patient's quality of life as well as in his work and social performance. There are different therapies that have not been totally effective for the management of this pathology, for that reason it is necessary to look for cost-effective options and the reach of all the patients to obtain remission of the symptoms.
Fibromyalgia affects 1-4% of the general population, patients manifest chronic pain and other comorbidities such as sleep disorders, fatigue, depression, psychological stress and cognitive disturbances. It is a significant cause of loss of employment and disconnection from the social environment.
A longitudinal, prospective, randomized study with patients diagnosed with Fibromyalgia will be performed at the outpatient clinic of the Rheumatology Service at the University Hospital "Dr. José Eleuterio González "of the Autonomous University of Nuevo León.
DEFINITION OF VARIABLES
Dependent variable:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind, the subject of study and researcher.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 18 years.
- •Patients who agree to participate in the study.
- •Those that meet the ACR 1990 and 2010 criteria for Fibromyalgia.
- •No previous use of vitamin D.
- •Patients diagnosed with primary or secondary fibromyalgia.
排除标准
- •Those subjects with previous use of vitamin D.
- •Known subjects with renal, liver, calcium metabolism disorders, malabsorption disorders, known neoplasms.
- •Subjects with serum calcium levels equal to or greater than 10.2 mg / dl.
研究组 & 干预措施
D3 Vitamin
In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.
干预措施: D3 Vitamin (Drug)
Placebo
In this group the subjects will receive 1 placebo capsule each week for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
FIBROMYALGIA IMPACT QUESTIONNAIRE
时间窗: 12 weeks
Number of items in scale: The version from 19911 consisted of 10 items with 10 sub-items in the physical function scale (total items + sub-items = 19). The modified version from 1997 consists of 20 items with 11 physical function items (total items + sub-items = 30). The 2009 version consists of 21 items across the 3 domains of Function (n = 9), Overall Impact (n = 2), and Symptoms (n = 10). Subscales: Subscales from the 1991 version1 include physical function (10 sub-items), feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), anxiety (1 item), and depression (1 item).
次要结局
- VISUAL ANALOGUE SCALE(12 weeks)
研究者
Luis Ivan Lozano Plata
Dr.
Universidad Autonoma de Nuevo Leon
