Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
Condition: Vitamin D Deficiency; Metabolic Syndrome; Prediabetes
MeSH terms: Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and efficacy of two different amounts of
      vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the
      daily meals versus same doses of vitamin D3 provided as oral supplements sold in any
      drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D
      deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic
      syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for
      heart disease and other health problems, such as diabetes and stroke as described by the US
      department of Health and Human Services.

      This study will also attempt to demonstrate and compare the effect of the intervention with
      above two doses of vitamin D on blood levels of tests that show inflammation.
    

Detailed description: 
      Poor vitamin D status is now considered epidemic in North America. In addition to its effects
      on bone metabolism, Vitamin D has several other important biological effects including
      modulating the immune system, stimulating the production of insulin and decreasing renin
      production in the kidney. Furthermore, the active metabolite of vitamin D, 1,25
      dihydroxyvitamin D (1,25(OH)2D), is a very potent inhibitor of cellular proliferation and
      inducer of terminal differentiation and vitamin D deficiency has been associated with higher
      prevalence of cancer, autoimmune diseases, including multiple sclerosis, rheumatoid
      arthritis, type 1 diabetes and hypertension.

      The current recommendations for dietary vitamin D in North America are much too low to
      maintain optimal levels of 25(OH)D associated with disease prevention. The majority of
      circulating 25(0H) D originates from cutaneous synthesis upon exposure to adequate sunlight.
      However, seasonal changes, living at high latitudes or low polluted altitudes, dark skin
      pigmentation and aging are among the many factors that can impede this process requiring
      periodic reliance on dietary sources to supply the precursor to 25(OH)D.

      In November of 2010, the Institute of Medicine (IOM) of the National Academy of Science
      established new DRI values for vitamin: EAR (Estimated Average Requirement) of 400 IU (10 µg;
      RDA ( Recommended Daily Intake) of 600 IU (15µg) for adults up to 70 years of age, and an UL
      of 4000 IU (50µg) (21). The IOM also discourages the taking of dietary supplements to achieve
      the RDA for vitamin D and encourages Americans to achieve their needed vitamin D through food
      sources.

      The proposed study will be to provide meals with one serving of fresh mushroom per day that
      could have two different levels of vitamin D2 in it (600 IU or 4,000 IU/day, which are the
      2011 currently recommended RDA to age 70 AI and UL, respectively) for four months and test
      both the bioavailability of vitamin D in mushroom, as reflected in blood 25(OH)D levels, as
      well as the effect of vitamin D on markers of disease (e.g. C-reactive protein (CRP),
      Hemoglobin A1c, etc). The vitamin D2 amount in mushrooms can easily be manipulated just by
      adjusting the time and distance of their UVB exposure. Two groups will be compared with
      controls who will receive the same dose of vitamin D3 in the form of tablets commercially
      available (600 IU or 4000 IU/day).
    

Intervention name(s): Mushroom with 600 IU vitamin D2; Mushroom with 4000 IU Vitamin D2; 600 IU Vitamin D3 and untreated mushroom; 4000 IU Vitamin D3 and untreated mushroom; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Subjects in this group will eat daily meals containing mushrooms fortified with 600 IU of Vitamin D2. These subjects will also take one placebo tablet per day.; Subjects in this group will eat daily meals containing mushrooms fortified with 4000 IU of Vitamin D2. These subjects will also take one placebo tablet per day.; Subjects in this group will take one commercially available tablet of 600 IU of Vitamin D3. These subjects will also eat one meal per day with untreated (inactive) mushrooms.; Subjects in this group will take one commercially available tablet of 4000 IU of Vitamin D3. These subjects will also eat one meal per day with untreated (inactive) mushrooms.; Placebo for the fortified mushroom arms
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; Mushroom; Cholecalciferol; Prediabetes; Metabolic Syndrome