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Evaluating Vitamin D Content in Mushrooms

Not Applicable
Completed
Conditions
Vitamin D Deficiency
Interventions
Dietary Supplement: Mushroom Vitamin D2
Dietary Supplement: Cholecalciferol
Dietary Supplement: Mushroom Extract
Dietary Supplement: Vitamin D2 - Ergocalciferol
Registration Number
NCT01815437
Lead Sponsor
Boston University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2000 IU Mushroom Vitamin D2Mushroom Vitamin D2Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks
2000 IU Vitamin D3- CholecalciferolCholecalciferolTake 2000 IU crystalline vitamin D3 once/day for 12 weeks.
Mushroom ExtractMushroom ExtractCapsules with mushroom extract and no vitamin D. The intervention is mushroom extract.
2000 IU Vitamin D2- ErgocalciferolVitamin D2 - ErgocalciferolTake 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.
Primary Outcome Measures
NameTimeMethod
Changes in total 25(OH)D in mushroom supplement or crystalline supplement12 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 Outcome Measures
NameTimeMethod
Changes in gene expression due to mushroom supplement or crystalline supplement12 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.

Trial Locations

Locations (1)

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

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