Evaluating Vitamin D Content in Mushrooms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Vitamin D in a Mushroom Supplement

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Mushroom Vitamin D2
* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Vitamin D2 - Ergocalciferol
* Dietary Supplement: Mushroom Extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2000 IU Vitamin D3- Cholecalciferol<br>Take 2000 IU crystalline vitamin D3 once/day for 12 weeks. | Dietary Supplement: Cholecalciferol<br>* 2000 IU crystalline cholecalciferol once/day for 12 weeks<br>|
| Active Comparator: 2000 IU Vitamin D2- Ergocalciferol<br>Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks. | Dietary Supplement: Vitamin D2 - Ergocalciferol<br>* 2000 IU vitamin D2, ergocalciferol once/day for 12 weeks<br>* Other names: Ercocalciferol;|
| Experimental: 2000 IU Mushroom Vitamin D2<br>Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks | Dietary Supplement: Mushroom Vitamin D2<br>* 2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks<br>* Other names: Ergocalciferol;|
| Placebo Comparator: Mushroom Extract<br>Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract. | Dietary Supplement: Mushroom Extract<br>* Same quantity of mushroom extract in a capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total 25(OH)D in mushroom supplement or crystalline supplement | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gene expression due to mushroom supplement or crystalline supplement | 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. | 12 weeks |