Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Effect of Vitamin D Supplementation on Fasting Glucose and IL-10 in Arab Women With Impaired Fasting Glucose.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- fasting glucose
研究概览
简要总结
Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is highly prevalent among Arab women in Israel and the Middle East. Since life style modification is difficult to achieve in this population it is important to assess whether other modifiable risk factors can be detected. There is evidence that the homeostasis of vitamin D has a significant role in the eventual development of diabetes. Previous cross sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that vitamin D supplementation may improve IFG and by that reduce the risk for future overt diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there is an increased production and secretion of a wide range of inflammatory molecules including interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.
详细描述
Eligible women will be invited by their primary care physician to participate in the study. After signing an informed consent women will be randomized to receive oral vitamin D 100,000 IU or similar placebo once a month for three consecutive months. Pertinent clinical and demographic date will be documented and relevant laboratory test will be performed by the primary care team. One month after the third dose the same data and tests will be retrieved on each woman. Compliance with the study protocol will be enhanced and confirmed by a research assistant.
Objectives:
To assess the relationship between IFG and 25(OH) vitamin D levels in overweight Arab women.
To assess whether vitamin D supplementation significantly improves IFG. To assess whether vitamin D supplementation significantly modifies IL-10 and hs-CRP.
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)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Arab women, age 40-65
- •No significant handicap or disabilities in ADL
- •BMI > 25 kg/m2
- •IFG of 100-125 mg/dl
排除标准
- •Diabetes Mellitus
- •Other medical conditions that may have an effect on IFG (cancer, chronic renal failure, inflammatory diseases etc)
- •History of vascular disease
- •Regular use of medications that may affect IFG (steroids, HRT, diuretics etc)
- •Hypercalcemia (albumin corrected Ca >10.3 mg/dl)
- •Inability to sign an informed consent due to mental or psychiatric ailment
研究组 & 干预措施
Vitamin D
Intervention arm: Oral vitamin D 100,000 IU once a month for three consecutive months.
干预措施: Oral vitamin D 100,000 IU (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
fasting glucose
时间窗: 4 months
interleukin-10 level
时间窗: 4 months
次要结局
- hs-CRP level(4 months)
研究者
Uzi Milman
Director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL.
Clalit Health Services
