Vitamin D DeficiencyNCT01488734
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
A study testing Mushroom with 600 IU vitamin D2, Mushroom with 4000 IU Vitamin D2 and 600 IU Vitamin D3 and untreated mushroom in people with Vitamin D Deficiency and Metabolic Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Vitamin D Deficiency, Metabolic Syndrome, Prediabetes
- What is being tested?
- Mushroom with 600 IU vitamin D2, Mushroom with 4000 IU Vitamin D2 and 600 IU Vitamin D3 and untreated mushroom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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%
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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 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.
The 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.
In 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.
The 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).
- Conditions
- Vitamin D Deficiency, Metabolic Syndrome, Prediabetes
- Being tested
- Mushroom with 600 IU vitamin D2, Mushroom with 4000 IU Vitamin D2, 600 IU Vitamin D3 and untreated mushroom, 4000 IU Vitamin D3 and untreated mushroom, Placebo
- Keywords
- Vitamin D, Mushroom, Cholecalciferol, Prediabetes, Metabolic Syndrome
- Medical subject headings
- Vitamin D Deficiency, Metabolic Syndrome, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom with 600 IU vitamin D2Dietary supplement
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.
Mushroom with 4000 IU Vitamin D2Dietary supplement
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.
600 IU Vitamin D3 and untreated mushroomDietary supplement
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.
4000 IU Vitamin D3 and untreated mushroomDietary supplement
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.
PlaceboDrug
Placebo for the fortified mushroom arms
| Study group | Role | What they receive |
|---|---|---|
| Mushroom with 600 IU vitamin D2 | Experimental | Mushroom with 600 IU of vitamin D2 daily and placebo tablet Receives: Dietary Supplement: Mushroom with 600 IU vitamin D2; Drug: Placebo |
| Mushroom with 4000 IU Vitamin D2 | Experimental | Mushroom with 4000 IU of Vitamin D2 daily and placebo tablet Receives: Dietary Supplement: Mushroom with 4000 IU Vitamin D2; Drug: Placebo |
| 600 IU Vitamin D3 and untreated mushroom | Active comparator | Commercially available tablets with 600 IU/day of Vitamin D3 and untreated mushroom Receives: Dietary Supplement: 600 IU Vitamin D3 and untreated mushroom |
| 4000 IU Vitamin D3 and untreated mushroom | Active comparator | Commercially available tablets with 4000 IU/day of Vitamin D3 and untreated mushroom Receives: Dietary Supplement: 4000 IU Vitamin D3 and untreated mushroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 4 months
Secondary outcomes (5)
Serum calcium
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)
Measured: at 1 month
Serum calcium
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)
Measured: at 2 months
Serum calcium
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)
Measured: at 3 months
Serum calcium
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)
Measured: at 4 months
Markers of inflammation and metabolic control
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).
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaime Uribarri, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488734
- Sponsor's protocol ID
- GCO 11-0899
- Other IDs
- 11-01366
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2011
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
- ClinicalTrials.gov ID
- NCT01488734
- Acronym / sponsor ID
- GCO 11-0899
- Conditions
- Vitamin D Deficiency, Metabolic Syndrome, Prediabetes
- Keywords
- Vitamin D, Mushroom, Cholecalciferol, Prediabetes, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
The 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.
In 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.
The 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mushroom with 600 IU vitamin D2 | Experimental | Dietary Supplement: Mushroom with 600 IU vitamin D2, Drug: PlaceboMushroom with 600 IU of vitamin D2 daily and placebo tablet |
| Mushroom with 4000 IU Vitamin D2 | Experimental | Dietary Supplement: Mushroom with 4000 IU Vitamin D2, Drug: PlaceboMushroom with 4000 IU of Vitamin D2 daily and placebo tablet |
| 600 IU Vitamin D3 and untreated mushroom | Active comparator | Dietary Supplement: 600 IU Vitamin D3 and untreated mushroomCommercially available tablets with 600 IU/day of Vitamin D3 and untreated mushroom |
| 4000 IU Vitamin D3 and untreated mushroom | Active comparator | Dietary Supplement: 4000 IU Vitamin D3 and untreated mushroomCommercially available tablets with 4000 IU/day of Vitamin D3 and untreated mushroom |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult non-smoking subjects from ages 30 to 90, any race or gender
- Presence of at least two of the following characteristics:
- Men: > 102 cm Women: > 88 cm
- Blood pressure: > 130/85 mm Hg (or use of anti-BP medication)
- HDL-cholesterol:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mushroom with 600 IU vitamin D2Subjects 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 600 IU vitamin D2 |
| Mushroom with 4000 IU Vitamin D2Subjects 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 | Mushroom with 4000 IU Vitamin D2 |
| 600 IU Vitamin D3 and untreated mushroomSubjects 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 | 600 IU Vitamin D3 and untreated mushroom |
| 4000 IU Vitamin D3 and untreated mushroomSubjects 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. | Dietary supplement | 4000 IU Vitamin D3 and untreated mushroom |
| PlaceboPlacebo for the fortified mushroom arms | Drug | Mushroom with 4000 IU Vitamin D2, Mushroom with 600 IU vitamin D2 |
Primary outcome
25OH Vitamin D level
Time frame: at 4 months
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.
5 secondary outcomes
Serum calcium
Time frame: at 1 month
Serum calcium
Time frame: at 2 months
Serum calcium
Time frame: at 3 months
Serum calcium
Time frame: at 4 months
Markers of inflammation and metabolic control
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Uribarri, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom with 600 IU vitamin D2, Mushroom with 4000 IU Vitamin D2 and 600 IU Vitamin D3 and untreated mushroom in people with Vitamin D Deficiency and Metabolic Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25OH Vitamin D level (time frame: at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.