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Completed

NCT Number: NCT01815437

Evaluating Vitamin D Content in Mushrooms

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mushroom Vitamin D2

Dietary Supplement

2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks

Other names: Ergocalciferol

Cholecalciferol

Dietary Supplement

2000 IU crystalline cholecalciferol once/day for 12 weeks

Vitamin D2 - Ergocalciferol

Dietary Supplement

2000 IU vitamin D2, ergocalciferol once/day for 12 weeks

Other names: Ercocalciferol

Mushroom extract

Dietary Supplement

Same quantity of mushroom extract in a capsule

Primary outcomes

  1. 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

  1. Changes in gene expression due to mushroom supplement or crystalline supplement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Evaluation of Vitamin D in a Mushroom Supplement

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2013
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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