Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assess improved fatigue among patients with Crohn's Disease
研究概览
简要总结
This study includes an open label clinical trial comparing two doses of CoQ10 for 8 weeks to improve fatigue among patients with Crohn's disease and a prospective cohort study of healthy controls taking CoQ10 for 2 weeks. Additionally, among 15 participants who do not meet the fatigue threshold for the open label trial, the investigators will measure CoQ10 levels in blood and fasting urine, as well as complete the same data collection.
Hypotheses
- Fatigue will improve with CoQ10 and there will be a dose response with greater improvement with higher dose as measured by the Patient Reported Outcomes Measurement Information Systems Fatigue PROMIS Fatigue 7a instrument.
- Fatigue will improve when measured with other fatigue scales in a similar dose dependent manner and that general and physical fatigue will improve more than mental fatigue.
- CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •for all study participants
- •To be eligible for this study all study participants must meet the following:
- •Provide informed consent
- •Male or female, age 18-70
- •Ability to take an oral medication
- •Willingness and ability to do electronic surveys
- •Additional inclusion criteria for Cohort 1 and Cohort 2 participants:
- •Must have Crohn's disease for at least 3 months
- •Must be on stable medication regimen for Crohn's disease for at least 4 weeks
- •Clinically quiescent Crohn's disease based on the Patient Reported Outcome -Crohn's Disease (PRO2) average score for up to 7 days - daily liquid or very soft stool frequency of ≤1.5 and abdominal pain ≤1.0 5.3 Additional inclusion criteria for Cohort 1
- •1. Prescreening PROMIS Fatigue 7a T score >60 5.4 Additional inclusion criteria for Cohort 2 and 3
- •1. Prescreening PROMIS Fatigue 7a T score <55
排除标准
- •for all study participants
- •Pregnant or lactating - a blood pregnancy test will be administered - fatigue is common with pregnancy and the post-partum period and is more likely to be unrelated to Crohn's
- •Chronic fatigue syndrome - noted in the medical record or self-reported
- •Depression as measured with PROMIS Depression scale 7a with T score >=60
- •New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record
- •Untreated sleep apnea
- •Abnormal Thyroid Stimulating Hormone (TSH) - <0.45 μlU/mL or >5.33 μlU/mL
- •Iron deficiency or anemia - ferritin < 20 without anemia or <100 with anemia (hemoglobin < 12g/dL in females or 13.5 g/dL in males) on the screening laboratory tests
- •B12 deficiency - <180 pg/mL on the screening laboratory tests
- •Stage 3B or higher Chronic Kidney Disease (CKD) - based on an estimated glomerular filtration rate (eGFR) < 45 ml/min on the screening laboratory tests
- •Diagnosis of cirrhosis - if noted in the medical record or self-reported
- •Diagnosis of primary sclerosing cholangitis
- •Diagnosis with hepatitis C without evidence of successful eradication
- •Cancer and receiving chemotherapy - if noted in the medical record or self-reported
- •Multiple Sclerosis - self-reported on in chart.
- •Taking systemic corticosteroids (e.g. prednisone or budesonide), not including single doses given to prevent adverse reactions to a medication or contrast agent
- •Taking warfarin - if noted in the medical record or self-reported
- •Diabetes requiring medication - if noted in the medical record or self-reported
- •Symptoms of an infection in the last 2 weeks - self-reported
- •Any other comorbidity or condition that the PI thinks is a contraindication to participation in this study
- •Exclusion Criteria for Cohorts 1 and 3
- •1. Previous intolerance to CoQ10
研究组 & 干预措施
Cohort 3 Healthy Volunteers
干预措施: CoQ10 (Drug)
Cohort 1 Crohn's Disease Patients with Fatigue
干预措施: CoQ10 (Drug)
Cohort 2 Crohn's Disease without Fatigue
结局指标
主要结局
Assess improved fatigue among patients with Crohn's Disease
时间窗: 8 weeks
The primary objective of this study is to assess whether there is sufficient evidence of a change (greater than 7 points) in fatigue among patients with Crohn's disease taking CoQ10 to warrant conduct of a larger, placebo-controlled clinical trial. The primary outcome will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, a unidimensional scale that has been well validated and tested among the general population and patients with IBD and many other chronic disorders. The scale ranges from 33.7 to 75.8. Higher scores indicate more greater fatigue.
次要结局
- Change in domain specific fatigue(8 weeks)