Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMushroom Vitamin D2
2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
DIETARY_SUPPLEMENTCholecalciferol
2000 IU crystalline cholecalciferol once/day for 12 weeks
DIETARY_SUPPLEMENTVitamin D2 - Ergocalciferol
2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
DIETARY_SUPPLEMENTMushroom Extract
Same quantity of mushroom extract in a capsule
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total 25(OH)D in mushroom supplement or crystalline supplement | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in gene expression due to mushroom supplement or crystalline supplement | 12 weeks | The secondary outcome is to look at changes in gene expression, specifically if ingestion of 2000 IU vitamin D2 in a dried mushroom extract and the same quantity of mushroom extract once/day for three months has any added benefits or differences compared to taking crystalline vitamin D2 or vitamin D3. |
Countries
United States
Outcome results
None listed