The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Endotoxin Activity
研究概览
简要总结
The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease.
We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.
详细描述
Your participation in this study requires:
- 4 visits to the outpatient clinic (including 1 screening visit)
- Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit
- Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Healthy volunteers
- •Males and post-menopausal females, between the age of 50 -
- •Vitamin D 25-OH level less than 20 ng/ml
- •Inclusion Criteria for Medium-level Kidney Function volunteers
- •Males and post-menopausal females, between the age of 50 -
- •Chronic kidney disease stage 3
- •Vitamin D 25-OH level less than 20 ng/ml
排除标准
- •Serum calcium level >10.5 mg/dl
- •Serum phosphorus level > 5.5 mg/dl
- •Serum PTH level < 35 pg/ml
- •Active infection including HIV, Hepatitis B or C
- •History of recent acute infection ( within 1 month)
- •Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
- •Hgb< 10 g/dL
- •Current use of Coumadin
- •Current use of Vitamin D >400 IU/day
- •Current use of systemic steroids or other immunosuppressants
- •History of malignancy not in remission (>6 months)
- •History of current ethanol abuse or illicit drug use
- •History of significant emotional disorder within the past 5 years
- •Participation in an investigational drug study within one month of screening
- •Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
研究组 & 干预措施
Vitamin D3
Vitamin D3 30,000 international units orally per week for 8 weeks
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Change in Endotoxin Activity
时间窗: baseline and 8 weeks
Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).
次要结局
- Blood Pressure(after 8 weeks of vitamin D therapy)
- 25-hydroxy Vitamin D (25-OH Vitamin D)(after 8 weeks of vitamin D therapy)
- Nuclear Magnetic Resonance (NMR) Lipoprotein Profile(after 8 weeks of vitamin D therapy)
- Intestinal Permeability(after 8 weeks of vitamin D therapy)
- 1, 25-OH Vitamin D(after 8 weeks of vitamin D therapy)
研究者
Manish Ponda
Assistant Professor of Clinical Investigation
Rockefeller University