Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

Completed · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency, Metabolic Syndrome, Prediabetes

In brief

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.

Key facts

Study ID

NCT01488734

Run by

Icahn School of Medicine at Mount Sinai

People needed

47

Starts

2011-11-01

Expected to finish

2013-09-01

Last updated by the study team

2017-04-14

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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