- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488734
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult non-smoking subjects from ages 30 to 90, any race or gender
Presence of at least two of the following characteristics:
- Waist circumference:
Men: > 102 cm Women: > 88 cm
- Blood pressure: > 130/85 mm Hg (or use of anti-BP medication)
- HDL-cholesterol:
Men: < 40 mg/dL Women: < 50 mg/dL
- Triglycerides: > 150 mg/dL (or use of medications for high triglycerides such as fibrates or nicotinic acid)
- Fasting blood sugar > 100 mg/dl (or use of metformin), but a HbA1c < 6.5%
Exclusion Criteria:
- Blood levels of 25(OH)D > 50 nmol/L
- Regular intake of vitamin D fortified milk exceeding approximately 3 glasses/day
- Lack of the ability to comprehend instructions and/or sign the consent form
- Inability to comply with the potential requirement to eat a daily portion of provided mushroom together with meals
- Inability to comply with the rule of avoiding any beach days during the duration of the study
- Any projected trip to sunny places such as Puerto Rico and the Caribbean during the period of study
- Any attendance to tanning studios during the period of study
- Women who regularly use a veil over their heads
- Any history of kidney stone formation
- Non-traumatic bone fracture over the past 3 years
- Any form of vitamin D supplement intake, including combined calcium and vitamin D products
- Active smoking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mushroom with 600 IU vitamin D2
Mushroom with 600 IU of vitamin D2 daily and placebo tablet
|
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.
Placebo for the fortified mushroom arms
|
EXPERIMENTAL: Mushroom with 4000 IU Vitamin D2
Mushroom with 4000 IU of Vitamin D2 daily and placebo tablet
|
Placebo for the fortified mushroom arms
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.
|
ACTIVE_COMPARATOR: 600 IU Vitamin D3 and untreated mushroom
Commercially available tablets with 600 IU/day of Vitamin D3 and untreated mushroom
|
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.
|
ACTIVE_COMPARATOR: 4000 IU Vitamin D3 and untreated mushroom
Commercially available tablets with 4000 IU/day of Vitamin D3 and untreated mushroom
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
25OH Vitamin D level
Time Frame: at 4 months
|
To compare the efficacy of two different doses of vitamin D2 (600 or 4000 IU/day) provided by Vitamin D2 fortified mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements in reaching adequate or optimal circulating levels of 25(OH) D in a racially diverse group of subjects with Vitamin D deficiency and pre-diabetes or the metabolic syndrome.
|
at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum calcium
Time Frame: at 1 month
|
To assess the safety of the intervention with respect to serum calcium levels in all study subjects.
Measured at each study visit (1, 2, 3, and 4 months)
|
at 1 month
|
Serum calcium
Time Frame: at 2 months
|
To assess the safety of the intervention with respect to serum calcium levels in all study subjects.
Measured at each study visit (1, 2, 3, and 4 months)
|
at 2 months
|
Serum calcium
Time Frame: at 3 months
|
To assess the safety of the intervention with respect to serum calcium levels in all study subjects.
Measured at each study visit (1, 2, 3, and 4 months)
|
at 3 months
|
Serum calcium
Time Frame: at 4 months
|
To assess the safety of the intervention with respect to serum calcium levels in all study subjects.
Measured at each study visit (1, 2, 3, and 4 months)
|
at 4 months
|
Markers of inflammation and metabolic control
Time Frame: at 4 months
|
To demonstrate and compare the effect of the intervention with above two doses of vitamin D on circulating levels of markers of inflammation and metabolic control (CRP, tumor necrosis factor (TNF), hemoglobin A1c, insulin, blood glucose, lipids).
|
at 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Nutrition Disorders
- Insulin Resistance
- Hyperinsulinism
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Hyperglycemia
- Metabolic Syndrome
- Vitamin D Deficiency
- Prediabetic State
- Glucose Intolerance
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- GCO 11-0899
- 11-01366
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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