Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 2:45 AM
Study NCT ID:
NCT01488734
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25OH Vitamin D level', 'timeFrame': 'at 4 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Serum calcium', 'timeFrame': 'at 1 month', 'description': '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)'}, {'measure': 'Serum calcium', 'timeFrame': 'at 2 months', 'description': '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)'}, {'measure': 'Serum calcium', 'timeFrame': 'at 3 months', 'description': '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)'}, {'measure': 'Serum calcium', 'timeFrame': 'at 4 months', 'description': '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)'}, {'measure': 'Markers of inflammation and metabolic control', 'timeFrame': 'at 4 months', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Mushroom', 'Cholecalciferol', 'Prediabetes', 'Metabolic Syndrome'], 'conditions': ['Vitamin D Deficiency', 'Metabolic Syndrome', 'Prediabetes']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult non-smoking subjects from ages 30 to 90, any race or gender\n* Presence of at least two of the following characteristics:\n\n * Waist circumference:\n\nMen: \\> 102 cm Women: \\> 88 cm\n\n* Blood pressure: \\> 130/85 mm Hg (or use of anti-BP medication)\n* HDL-cholesterol:\n\nMen: \\< 40 mg/dL Women: \\< 50 mg/dL\n\n* Triglycerides: \\> 150 mg/dL (or use of medications for high triglycerides such as fibrates or nicotinic acid)\n* Fasting blood sugar \\> 100 mg/dl (or use of metformin), but a HbA1c \\< 6.5%\n\nExclusion Criteria:\n\n* Blood levels of 25(OH)D \\> 50 nmol/L\n* Regular intake of vitamin D fortified milk exceeding approximately 3 glasses/day\n* Lack of the ability to comprehend instructions and/or sign the consent form\n* Inability to comply with the potential requirement to eat a daily portion of provided mushroom together with meals\n* Inability to comply with the rule of avoiding any beach days during the duration of the study\n* Any projected trip to sunny places such as Puerto Rico and the Caribbean during the period of study\n* Any attendance to tanning studios during the period of study\n* Women who regularly use a veil over their heads\n* Any history of kidney stone formation\n* Non-traumatic bone fracture over the past 3 years\n* Any form of vitamin D supplement intake, including combined calcium and vitamin D products\n* Active smoking'}, 'identificationModule': {'nctId': 'NCT01488734', 'briefTitle': 'Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom', 'orgStudyIdInfo': {'id': 'GCO 11-0899'}, 'secondaryIdInfos': [{'id': '11-01366'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mushroom with 600 IU vitamin D2', 'description': 'Mushroom with 600 IU of vitamin D2 daily and placebo tablet', 'interventionNames': ['Dietary Supplement: Mushroom with 600 IU vitamin D2', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Mushroom with 4000 IU Vitamin D2', 'description': 'Mushroom with 4000 IU of Vitamin D2 daily and placebo tablet', 'interventionNames': ['Dietary Supplement: Mushroom with 4000 IU Vitamin D2', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '600 IU Vitamin D3 and untreated mushroom', 'description': 'Commercially available tablets with 600 IU/day of Vitamin D3 and untreated mushroom', 'interventionNames': ['Dietary Supplement: 600 IU Vitamin D3 and untreated mushroom']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4000 IU Vitamin D3 and untreated mushroom', 'description': 'Commercially available tablets with 4000 IU/day of Vitamin D3 and untreated mushroom', 'interventionNames': ['Dietary Supplement: 4000 IU Vitamin D3 and untreated mushroom']}], 'interventions': [{'name': 'Mushroom with 600 IU vitamin D2', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Mushroom with 600 IU vitamin D2']}, {'name': 'Mushroom with 4000 IU Vitamin D2', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Mushroom with 4000 IU Vitamin D2']}, {'name': '600 IU Vitamin D3 and untreated mushroom', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['600 IU Vitamin D3 and untreated mushroom']}, {'name': '4000 IU Vitamin D3 and untreated mushroom', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['4000 IU Vitamin D3 and untreated mushroom']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for the fortified mushroom arms', 'armGroupLabels': ['Mushroom with 4000 IU Vitamin D2', 'Mushroom with 600 IU vitamin D2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jaime Uribarri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}