NCT01852903已完成不适用
A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
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
- 40
- 试验地点
- 2
- 主要终点
- Plasma and leukocyte vitamin C concentration
研究概览
简要总结
The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.
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 60 Years（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
- •BMI 18-30 kg/m2
- •Agrees to consume a low vitamin C diet
- •Non-smoker or ex-smoker >1 year
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant during the trial
- •Alcohol >2 drinks per day; alcohol or drug abuse within the past year
- •Cardiac conditions
- •Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
- •History irritable bowel syndrome, malabsorption or significant GI disease
- •History of kidney stones
- •Use of medications known to interact with vitamin C
- •Use of supplements containing vitamin C
- •Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
- •History of or current diagnosis of cancer
- •Uncontrolled hypertension
- •History of diabetes, renal disease and/or liver disease
- •Unstable psychiatric disorder
- •History of or current immunocompromise
- •History of hemochromatosis or hemoglobinopathies
- •Participation in a clinical research trial <30 days
- •Use of acute medication w/in 72 hours of intervention
- •Unstable medications <90 days
- •Abnormal liver function
- •Serum creatinine > 1.5 x upper limit of normal (ULN)
- •Anemia of any etiology
- •Blood donation w/in the last 2 months
- •Allergy or sensitivity to test articles, foods or beverages provided during the study
- •Cognitive impairment and/or unable to give informed consent
结局指标
主要结局
Plasma and leukocyte vitamin C concentration
时间窗: 0, 2, 4, 8 and 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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