Status:
COMPLETED
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Vitamin D Deficiency
Metabolic Syndrome
Eligibility:
All Genders
30-90 years
Phase:
NA
Brief 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 versu...
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 immu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01488734
Start Date
November 1 2011
End Date
September 1 2013
Last Update
April 14 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029