Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

Metabolic Syndrome Clinical Trial

Official title:

Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488734
• Other study ID #: GCO 11-0899
• Secondary ID: 11-01366
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: April 12, 2017
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Prediabetes
• Prediabetic State
• Vitamin D Deficiency

Intervention

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	at 1 month
Secondary	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)	at 2 months
Secondary	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)	at 3 months
Secondary	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)	at 4 months
Secondary	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).	at 4 months