Evaluating Vitamin D Content in Mushrooms

Evaluation of Vitamin D in a Mushroom Supplement

Sponsors

Lead Sponsor: Boston University

Source 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.

Overall Status Completed
Start Date January 2012
Completion Date June 2013
Primary Completion Date June 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in total 25(OH)D in mushroom supplement or crystalline supplement 12 weeks
Secondary Outcome
Measure Time Frame
Changes in gene expression due to mushroom supplement or crystalline supplement 12 weeks
Enrollment 80
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Mushroom Vitamin D2

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

Arm Group Label: 2000 IU Mushroom Vitamin D2

Other Name: Ergocalciferol

Intervention Type: Dietary Supplement

Intervention Name: Cholecalciferol

Description: 2000 IU crystalline cholecalciferol once/day for 12 weeks

Arm Group Label: 2000 IU Vitamin D3- Cholecalciferol

Intervention Type: Dietary Supplement

Intervention Name: Vitamin D2 - Ergocalciferol

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

Arm Group Label: 2000 IU Vitamin D2- Ergocalciferol

Other Name: Ercocalciferol

Intervention Type: Dietary Supplement

Intervention Name: Mushroom Extract

Description: Same quantity of mushroom extract in a capsule

Arm Group Label: Mushroom Extract

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael F Holick, PhD, MD Principal Investigator Boston Medical Center
Location
Facility: Boston Medical Center
Location Countries

United States

Verification Date

March 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 2000 IU Vitamin D3- Cholecalciferol

Type: Active Comparator

Description: Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.

Label: 2000 IU Vitamin D2- Ergocalciferol

Type: Active Comparator

Description: Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.

Label: 2000 IU Mushroom Vitamin D2

Type: Experimental

Description: Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks

Label: Mushroom Extract

Type: Placebo Comparator

Description: Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov