Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
2 other identifiers
interventional
47
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 14, 2017
April 1, 2017
1.8 years
December 6, 2011
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
25OH Vitamin D level
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 Outcomes (5)
Serum calcium
at 1 month
Serum calcium
at 2 months
Serum calcium
at 3 months
Serum calcium
at 4 months
Markers of inflammation and metabolic control
at 4 months
Study Arms (4)
Mushroom with 600 IU vitamin D2
EXPERIMENTALMushroom with 600 IU of vitamin D2 daily and placebo tablet
Mushroom with 4000 IU Vitamin D2
EXPERIMENTALMushroom with 4000 IU of Vitamin D2 daily and placebo tablet
600 IU Vitamin D3 and untreated mushroom
ACTIVE COMPARATORCommercially available tablets with 600 IU/day of Vitamin D3 and untreated mushroom
4000 IU Vitamin D3 and untreated mushroom
ACTIVE COMPARATORCommercially available tablets with 4000 IU/day of Vitamin D3 and untreated mushroom
Interventions
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.
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.
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.
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.
Placebo for the fortified mushroom arms
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Uribarri, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
April 14, 2017
Record last verified: 2017-04