Evaluating Vitamin D Content in Mushrooms

March 23, 2017 updated by: Boston University

Evaluation of Vitamin D in a Mushroom Supplement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Michael F Holick, PhD, MD, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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