Evaluation of Vitamin D in a Mushroom Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in total 25(OH)D in mushroom supplement or crystalline supplement
研究概览
简要总结
This study will evaluate how much vitamin D is present in a mushroom supplement. This supplement contains an extract from mushrooms that have been exposed to sunlight. The mushroom supplement will be compared to non-commercially available vitamin D supplements produced in a Goo Manufacturing Practices (GMP)-licensed facility.
详细描述
Mushrooms have the capability to produce vitamin D in a similar way to human skin. When exposed to ultraviolet light, mushrooms will convert a precursor to vitamin D. This reaction produces large amounts of vitamin D. This study is comparing a natural source of vitamin D to a synthetic source of vitamin D and will help determine if mushrooms are a novel source for this essential nutrient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All healthy adults, male and female, age 18-64 years
排除标准
- •Currently taking, or having taken less than one month prior to start of study, a prescription of 50,000 IU of vitamin D2 or 2000 IU vitamin D2 or vitamin D3
- •Allergy to mushrooms
- •History of elevated calcium (>10.4 mg%)
- •Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- •Supplementation with over the counter formulations of vitamin D2 or vitamin D3
- •Subjects with a history of an adverse reaction to orally administered vitamin D.
- •Subjects who are taking oral Dilantin or glucocorticoids.
- •Exposure to a tanning bed or tanning on a beach for more than eight hours with no sunscreen within 2 weeks prior to start of study.
- •History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
- •Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
结局指标
主要结局
Changes in total 25(OH)D in mushroom supplement or crystalline supplement
时间窗: 12 weeks
The primary outcome of this study is to examine changes in total 25(OH)D levels after ingestion of a vitamin D2 mushroom supplement manufactured by Monterey Mushrooms, Inc. compared to crystalline vitamin D2 from Nature's Life or vitamin D3 manufactured by Whole Health, Inc.
次要结局
- Changes in gene expression due to mushroom supplement or crystalline supplement(12 weeks)