Evaluating Vitamin D Content in Mushrooms
|ClinicalTrials.gov Identifier: NCT01815437|
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment|
|Vitamin D Deficiency||Dietary Supplement: Mushroom Vitamin D2 Dietary Supplement: Cholecalciferol Dietary Supplement: Vitamin D2 - Ergocalciferol Dietary Supplement: Mushroom Extract|
|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|
|Primary Completion Date :||June 2013|
|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.
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|