NCT03552653已完成不适用
A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Mean Absorption
研究概览
简要总结
The objective of this study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
详细描述
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same dose of gummy and tablet supplementation.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants not of childbearing potential (hysterectomy, oophorectomy, bilateral tubal ligation, postmenopausal) or females of childbearing potential that agree to use a medically approved method of birth control including hormonal contraceptives, double-barrier, non-hormonal intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner
- •BMI 18.5 to 29.9 kg/m2
- •Agrees to maintain current level of physical activity throughout the study
- •Agrees to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hour without sunblock)
排除标准
- •Women who are pregnant to be determined by UPT (uterine pregnancy test), breastfeeding, or planning to become pregnant during the course of the study
- •Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or GERD within the past 3 months
- •Significant gastrointestinal disease, history of malabsorption, or history of irritable bowel syndrome and related disorders
- •Unstable medical conditions as determined by the principal investigator
- •Clinically significant abnormal laboratory results on CBC or BMP at screening
- •Cancer chemotherapy/radiation treatment within the 3 months prior to enrollment
- •Metabolic disease
- •History of kidney stones
- •Use of prescription or over the counter products known to interact with vitamin D within 72 hours of randomization and during the trial such as aspirin and NSAIDs, aluminum, iron and proton pump inhibitors
- •Use of acute over the counter medication within 72 hours of test product dosing
- •Consumption of more than 2 alcoholic drinks per day
- •Drug abuse within the past year
- •Use of medicinal marijuana
- •Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with HIV (human immunodeficiency virus)
- •Use of St. John's wort in the last 30 days before randomization and during the study
- •Use of vitamin D, multivitamins containing vitamin D, foods or beverages fortified with vitamin D and other natural health products containing vitamin D, or consumption of grapefruit/ grapefruit juice within 14 days of randomization and during the study
- •Use of anticoagulants, barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
- •History of blood/bleeding disorders
- •Anemia of any etiology defined as hemoglobin < 140 g/L for males and < 123 g/L for females
- •Blood donation in the past 3 months, or individual planning to donate blood during the study or within 30 days of completion of study
- •Participation in a clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to any ingredient in supplements provided during the study
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
研究组 & 干预措施
Vitafusion Extra Strength Vitamin D3 Gummy
Experimental
Single oral dose of gummy vitamin D3 to monitor vitamin D blood levels
干预措施: Vitafusion Extra Strength Vitamin D (Dietary Supplement)
Nature Made Vitamin D3 Tablet
Active Comparator
Single oral dose of tablet vitamin D3 to monitor vitamin D blood levels
干预措施: Vitafusion Extra Strength Vitamin D (Dietary Supplement)
结局指标
主要结局
Mean Absorption
时间窗: baseline, 3, 6, 10, 24 and 48 hours
A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet)
次要结局
- Absorption Rate(0 to 48 hours)
研究者
研究点 (2)
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