Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

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.

Conditions

• Vitamin D Deficiency
• Metabolic Syndrome
• Prediabetes

Interventions

DIETARY_SUPPLEMENT

Mushroom with 600 IU vitamin D2

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.

DIETARY_SUPPLEMENT

Mushroom with 4000 IU Vitamin D2

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.

DIETARY_SUPPLEMENT

600 IU 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.

DIETARY_SUPPLEMENT

4000 IU 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.

DRUG

Placebo

Placebo for the fortified mushroom arms

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Jaime Uribarri, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States

Study Locations