Folate Absorption Across the Large Intestine, Study #2: Capsule Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Urine Folate - Study Period 1
研究概览
简要总结
The objective of this study is to determine whether the intact human colon with an unaltered microflora distribution absorbs folate and to what extent it is absorbed into the systemic circulation using a dual/oral intravenous route. This will elicit an understanding of colonic folate absorption and metabolism.
详细描述
This study supplements two earlier in print exploratory studies investigating the absorption of folate across the colon after an infusion during colonoscopy and a pre-trial with the purpose of determining dissolution characteristics of two placebo caplet formulations. Using a dual route oral/intravenous, folate (pharmaceutical name Calcium Leucovorin), labeled with a stable isotope will be used to quantitatively measure total folate levels, as well as the uptake of (13C) labeled folate. A pH dependent caplet targeted to the colon and fluoroscopy will determine dissolution characteristics. Labeled and unlabelled folate in blood and urine samples will be used to quantitatively measure the uptake of folate. This will further our understanding of the kinetics (caplet transit times), colonic folate absorption (metabolism) and impact on folate status (bioavailability) in healthy adults.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Age 18-65 years
- •Exclusion Criteria
- •<18 years of age, >65 years of age
- •chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, hematological, or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- •regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. anti-acid or nonsteroidal anti-inflammatory drugs [NSAIDS] such as aspirin/ibuprofen, phenytoin, sulfasalazine, phenobarbital, primidone, and cimetidine)
- •regularly consume > 1 drink of alcohol/d or current smoking (last 6 months)
- •planning a pregnancy, pregnant, breast feeding or the use of high-dose oral contraceptives/hormone replacement therapy
- •known sensitivity to Calcium Leucovorin
- •130mL of blood is > 5% of total blood volume
排除标准
- 未提供
研究组 & 干预措施
Capsule: 400 microg 13C5-Calcium-L-Leucovorin
干预措施: 13C5-Calcium-L-Leucovorin (Drug)
IV Injection: : 100 microg 13C5-Calcium-L-Leucovorin
干预措施: 13C5-Calcium-L-Leucovorin (Drug)
结局指标
主要结局
Urine Folate - Study Period 1
时间窗: 24h, 48h, 72h, 96h
Blood Folate - Study Period 1
时间窗: Day 1 (Baseline), Day 2 (0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Blood Folate - Study Period 2
时间窗: Day 2 (0h, 0.25h,0.5h,1h,1.5h,2h,2.5h,3h,3.5h,4h)
Urine Folate - Study Period 2
时间窗: 24h, 48h, 72h
次要结局
- Dietary Recall Records for folate analysis during urine collection days, Anthropometric.(Study Phase 1 (Day 2,Day 3,Day 4,Day 5) Study Period (Day 2,Day 3,Day 4))
研究者
Deborah O'Connor
Associate Chief, Clinical Dietetics
The Hospital for Sick Children