NCT01873820已完成不适用
A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NBTY, Inc.
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
研究概览
简要总结
The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy as determined by laboratory results and medical history
- •Females not of child bearing potential
- •Self-reported sensitivity to acidic foods
- •Agrees to consume a low vitamin C diet
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant during the trial
- •Use of medications known to interact with vitamin C or cause epigastric effects
- •Use of supplements containing containing vitamin C
- •Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
- •Use of antacids and/or acid suppressors within 4 weeks of randomization
- •History of irritable bowel syndrome and related disorders
- •Alcohol use > 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year
- •History of cardiac disease within the past 6 months
- •History of or current diagnosis of cancer
- •Uncontrolled hypertension
- •Unstable renal and/or liver disease
- •History of kidney stones
- •Unstable psychiatric disorder
- •History of or current immunocompromise
- •History of hemoglobinopathies
- •Participation in another clinical research trial <30 days
- •Abnormal liver function
- •Serum creatinine > 1.5 x upper limit of normal (ULN)
- •Anemia of any etiology
- •Uncontrolled and/or untreated thyroid disorder
- •BMI ≥ 35 kg/m2
- •Unstable medications <30 days
- •Allergy or sensitivity to test article ingredients
- •Cognitively impaired and/or unable to give informed consent
结局指标
主要结局
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
时间窗: 0, 5 and 10 days
次要结局
未报告次要终点
研究者
研究点 (2)
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