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临床试验/NCT01417923
NCT01417923Unknown4 期

The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
serologic inflamatory responses with prolong vitamin D therapy

研究概览

简要总结

Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial sources, and occurs naturally in a small range of foods.More recently, several reports underlined the impact of vitamin D on the prevalence and consequences of inadequate vitamin D intake and the research supporting its benefits for alleviating chronic musculoskeletal pain and fatigue syndromes in outpatients. Experts have recommended that vitamin D inadequacy should be addressed in all patients with bone or joint pain, myalgia, fibromyalgia, or chronic fatigue syndrome. It appears that soothing the daily musculoskeletal pain by supplementation of vitamin D may be a simple, well tolerated, and cost-effective modality.

Aim of study:

To study the potential therapeutic effects of vitamin D supplementation on patients with persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36 Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E will be assessed.

详细描述

The immune and clinical impacts of vitamin D in patients with chronic musculo-skeletal pain

Background Vitamin D is a group of fat-soluble secosteroids, the two major physiologically relevant forms are vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). Vitamin D without a subscript refers to either D2 or D3 or both. Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial sources, and occurs naturally in a small range of foods. Vitamin D is carried in the bloodstream to the liver, where it is converted into the prohormone calcidiol. Circulating calcidiol may then be converted into calcitriol, the biologically active form of vitamin D, either in the kidneys or by monocyte-macrophages in the immune system. When synthesized by monocyte-macrophages, calcitriol acts locally as a cytokine, defending the body against microbial invaders (1).

When synthesized in the kidneys, calcitriol circulates as a hormone, regulating among other things, the concentration of calcium and phosphate in the bloodstream, promoting the healthy mineralization, growth and remodeling of bone, and also vital to the normal function of the different arms of the immune system (1;2).

Vitamin D receptor activation in the intestine, bone, kidney, and parathyroid gland cells leads to the maintenance of calcium and phosphorus levels in the blood (with the assistance of parathyroid hormone and calcitonin) and to the maintenance of bone content. Vitamin D increases expression of the tyrosine hydroxylase gene in adrenal medullary cells. Vitamin D is involved in the biosynthesis of neurotrophic factors, synthesis of nitric oxide synthase, and increased glutathione levels. Adequate vitamin D may also be associated with healthy hair follicle growth cycles (3). Vitamin D insufficiency can result in thin and brittle bones, whereas sufficiency prevents rickets in children and osteomalacia in adults and helps to protect elderly from osteoporosis. Vitamin D has also direct on muscle strength and function (4;5). Nevertheless, there is no persuasive evidence of lower vitamin D status in chronic pain sufferers.

There are also associations between low 25(OH)D levels and peripheral vascular disease (6), certain cancers (7-10), multiple sclerosis (11), rheumatoid arthritis (12-15), juvenile diabetes (16-18), Parkinson's and Alzheimer's disease (19;20). However these associations were found in observational studies and vitamin D vitamin supplements have not been demonstrated to reduce the risks of these diseases.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • We enrolled patients suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months.

排除标准

  • Patients with low compliance
  • Allergy for vit D

研究组 & 干预措施

vitamin D

Experimental

We enrolled 80 patients of the age 18-80 years suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months. The 40 patients will receive daily doses of 4000 units of vitamin D for 6 weeks

干预措施: vitamin D (Drug)

结局指标

主要结局

serologic inflamatory responses with prolong vitamin D therapy

时间窗: 6 weeks

On the day of recruitment blood will be drawn in order to determine the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E2. Vitamin D or placebo will be taken for 6 weeks on top of the individual's daily medications. A second blood analysis will be conducted following the 6 week duration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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