Evaluation of Vitamin D in a Mushroom Supplement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in total 25(OH)D in mushroom supplement or crystalline supplement
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All healthy adults, male and female, age 18-64 years
Exclusion Criteria
- •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.
Arms & Interventions
2000 IU Vitamin D2- Ergocalciferol
Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.
Intervention: Vitamin D2 - Ergocalciferol (Dietary Supplement)
2000 IU Mushroom Vitamin D2
Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks
Intervention: Mushroom Vitamin D2 (Dietary Supplement)
Mushroom Extract
Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.
Intervention: Mushroom Extract (Dietary Supplement)
2000 IU Vitamin D3- Cholecalciferol
Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.
Intervention: Cholecalciferol (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in total 25(OH)D in mushroom supplement or crystalline supplement
Time Frame: 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.
Secondary Outcomes
- Changes in gene expression due to mushroom supplement or crystalline supplement(12 weeks)