Evaluation of the Bioavailability of Vitamin D2 in Yeast and Bread

NCT ID: NCT02720575

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

Brief Summary

The objective of this study is to test the bioavailability of vitamin D in bread.

Detailed Description

Vitamin D helps in reducing the risk for the development of many chronic diseases. Humans get vitamin D mainly from direct exposure to sunlight, from diet, or from dietary supplements. The bioavailability of vitamin D from dietary supplements has been tested. In one study, subjects had initial vitamin D level of less than 10ng/ml, and it rose to 60ng/ml 24 hours after taking a vitamin D supplement capsule that contained 50,000 IU of vitamin D2. Food contains vitamin D2 or vitamin D3 either naturally or after being fortified. Fortification of dietary products date back to the first half of the 20th century when Steenbock discovered that irradiation of food helped in promoting the healing of rickets in vitamin D deficient rachitic rats. Since that time, companies started to fortify their products to enhance their vitamin D content. In the 1930s Bond Bread fortified its bread with vitamin D2. Recently the FDA approved yeast vitamin D2 which is a yeast that was exposed to ultraviolet radiation. This yeast is active and when used to raise bread the bread contains vitamin D2. The baking process does not affect the vitamin D content. What is unknown is whether the vitamin D2 that is produced in the bread is bioavailable. The purpose of this study is to determine the bioavailability of vitamin D2 that is present in yeast, in bread that was raised with vitamin D2 yeast and vitamin D2 in the cell walls of yeast compared to a vitamin D2 supplement and a vitamin D3 supplement.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

A

50,000 IU of crystalline D2 in 5 capsules.. Vitamin D2 in its natural state consumed orally via capsule

Group Type: ACTIVE_COMPARATOR

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

B

50,000 IU of crystalline D3 in 5 capsules.. Vitamin D3 in its natural state consumed orally via capsule

Group Type: ACTIVE_COMPARATOR

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

C

50,000 IU of vitamin D2 from vitamin D2 yeast in 5 capsules. Vitamin D generated in yeast. Acts as a comparator to the yeast in bread.

Group Type: ACTIVE_COMPARATOR

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

D

50,000 IU of vitamin D2 from yeast cell walls in 5 capsules. Yeast cell walls rich in Vitamin D. Acts as a comparator to the yeast in bread.

Group Type: ACTIVE_COMPARATOR

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

E

50,000 IU of vitamin D2 from 2 slices of bread made from bread. Bread raised with yeast rich in vitamin D. Main experimental arm.

Group Type: EXPERIMENTAL

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

F

50,000 IU of vitamin D2 from 2 slices of bread. Bread raised with yeast and yeast cell walls rich in vitamin D.

Group Type: EXPERIMENTAL

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

Interventions

Consumption of capsule/bread with vitamin D

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female adult who are free of any chronic disease

2. Age 18-64 years

3. BMI <30kg/m2

4. No medications or disorders that would affect vitamin D metabolism

5. Women must be on birth control and not pregnant based on negative pregnancy test

6. Ability and willingness to give informed consent and comply with protocol

7. Subjects will be included in the study regardless of their baseline vitamin D level. This is because the level is undetectable unless the subjects is taking high amount of vitamin D, and we will be excluding subjects who are taking pharmacologic doses of vitamin D of >10,000 IUs. Doses of vitamin D in supplements typically contain 400 IUs and up to 1000 IUs. Taking this amount of vitamin D will not significantly raise blood levels of vitamin D from baseline which is usually less than 5 ng/mL. Taking 1000 IUs of vitamin D will raise the blood level by approximately 1-2 ng/mL. Taking a single dose of 50,000 IUs of vitamin D raises the blood level by 50-100 ng/mL. Also a person's vitamin D status i.e. serum 25-hydroxyvitamin D does not affect how vitamin D is absorbed by the intestine nor does it influence the response of oral vitamin D on blood levels of vitamin D which is the goal of this proposal.

Exclusion Criteria

• 1. Having history of hypercalcemia. 2. Taking over the counter or prescription vitamin D that is greater than 10,000 IUs daily.

3. Pregnancy. 4. History of intestinal malabsorption. 5. Inability to give informed consent. 6. Chronic hepatic or renal failure. 7. Subjects taking cholestyramine and olestra. 8. Celiac disease. 9. Allergy to wheat or gluten sensitivity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Michael F. Holick

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

H-833963

Identifier Type: -

Identifier Source: org_study_id