Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluating Vitamin D Content in Mushrooms

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01815437
First received: February 2, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Mushroom Vitamin D2
Dietary Supplement: Cholecalciferol
Dietary Supplement: Vitamin D2 - Ergocalciferol
Dietary Supplement: Mushroom Extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Evaluation of Vitamin D in a Mushroom Supplement

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Changes in total 25(OH)D in mushroom supplement or crystalline supplement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Changes in gene expression due to mushroom supplement or crystalline supplement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Cholecalciferol
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 Name: 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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815437

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Michael F Holick, PhD MD       mfholick@bu.edu   
Principal Investigator: Michael F Holick, PhD, MD         
Sub-Investigator: Jaimee M Bogusz, BS         
Sub-Investigator: Garyfallia Pagonis, BFA         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael F Holick, PhD, MD Boston Medical Center
  More Information

Publications:

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01815437     History of Changes
Other Study ID Numbers: MU100
Study First Received: February 2, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ergocalciferols
Vitamin D
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014