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临床试验/NCT00742781
NCT00742781已完成1 期

Vitamin D and Crohn's Disease" From the Bench to the Clinic

Penn State University4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
21
试验地点
4
主要终点
Crohn's Disease Activity Index

研究概览

简要总结

The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's disease patients. Patients will be evaluated for increases in circulating vitamin D levels and effects on health benefits including improved bone markers, Crohn's disease activity scores, and inflammatory markers.

详细描述

The incidence of autoimmune diseases like inflammatory bowel disease (IBD) has increased in developed countries over the last 50 years. We propose that decreased outdoor activity and increased pollution and diets that lack adequate vitamin D have combined to create large fluctuations in vitamin D status in developed countries and especially in populations that experience winter. Experimentally we've shown that changes in vitamin D status results in more severe forms of experimental IBD. In addition, active vitamin D (1,25(OH)2D3) completely blocks the development of experimental IBD. The vitamin D hypothesis proposes that vitamin D regulates the development and function of the immune system and that changes in vitamin D status affect the development of the resultant immune response and the development of diseases like IBD. Our hypothesis is that because of low dietary vitamin D intakes and malabsorption of many nutrients, Crohn's patients will have low circulating vitamin D levels that are detrimental for their health. We plan to give Crohn's patients 1000 IU of vitamin D/d and determine whether this dose is well tolerated, induces an increase in circulating vitamin D levels and has any additional health benefits (improved bone markers, Crohn's disease activity scores, inflammatory markers).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-70 years of age with mild to moderate Crohn's disease who are not on active steroid treatment and who do not have ostomies.

排除标准

  • Patients with ulcerative colitis or other bowel conditions which are not Crohn's.
  • Patients with ostomies.
  • Those currently using supplemental vitamin D in excess of the amount in one multivitamin per day.
  • Regular tanning bed users.
  • Persons who report more than moderate alcohol consumption ( > 1 drink/day for women > 2 for men).
  • Pregnant or lactating women or women planning a pregnancy during the study time frame.
  • Regular users of medications which may interfere with assessment of study outcomes .
  • Those who cannot understand written or spoken English .
  • Individuals under medical psychiatric care.

结局指标

主要结局

Crohn's Disease Activity Index

时间窗: 6 months

Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.

25(OH)D3 Serum Levels

时间窗: 6 months

25(OH)D3 levels before and after vitamin D supplementation.

次要结局

  • Health Improvement(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margherita T. Cantorna

Professor

Penn State University

研究点 (4)

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