NCT06266702已完成不适用
Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Vitamin D Absorption
研究概览
简要总结
This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult participants (18-55 years of age)
- •Body mass index (BMI) <30 kg/m2
- •Males and nonpregnant, nonlactating females
- •Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases
排除标准
- •Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.
- •Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.
- •Travel to sunny location within 3 weeks prior to the Screening Visit.
- •Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.
- •Has an allergy or intolerance to any ingredient in the study product.
- •Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.
- •Use of the following medications that may have interactions with vitamin D absorption or metabolism:
- •Aluminum-containing phosphate binders
- •Anticonvulsants
- •Atorvastatin
- •Calcipotriene
- •Cholestyramine
- •Cytochrome P-450 3A4 substrates
- •Diltiazem
- •Thiazide diuretics
- •Corticosteroids
- •Stimulant laxatives
- •Verapamil
结局指标
主要结局
Vitamin D Absorption
时间窗: Time 0 to 24 Hours
Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil
次要结局
- Vitamin D Absorption - Peak(Time 0 to 48 Hours)
- Vitamin D Absorption - AUC(Time 0 to 48 Hours)
研究者
研究点 (2)
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