Evaluating Vitamin D Content in Mushrooms
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|ClinicalTrials.gov Identifier: NCT01815437|
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Dietary Supplement: Mushroom Vitamin D2 Dietary Supplement: Cholecalciferol Dietary Supplement: Vitamin D2 - Ergocalciferol Dietary Supplement: Mushroom Extract||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Vitamin D in a Mushroom Supplement|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815437
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Michael F Holick, PhD, MD||Boston Medical Center|