Evaluation of the Bioavailability of Vitamin D2 in Yeast and Bread

NCT02720575 | Completed DMC

• 1 other identifier: H-833963
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Vitamin D; Bioavailability; Fortified Bread

Outcome Measures

Primary Outcomes (1)

• Evidence of serum vitamin D levels proceeding ingestion of bread raised with yeast containing vitamin D

  The subject blood will be monitored at the above mentioned time frame after consuming vitamin D in capsular or bread form.

  within the fist 24, 48, 72, 96, and 144 hours after ingestion

Study Arms (6)

A

ACTIVE COMPARATOR

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

Other: Consumption of capsule/bread with vitamin D

B

ACTIVE COMPARATOR

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

Other: Consumption of capsule/bread with vitamin D

C

ACTIVE COMPARATOR

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.

Other: Consumption of capsule/bread with vitamin D

D

ACTIVE COMPARATOR

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.

Other: Consumption of capsule/bread with vitamin D

E

EXPERIMENTAL

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.

Other: Consumption of capsule/bread with vitamin D

F

EXPERIMENTAL

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

Other: Consumption of capsule/bread with vitamin D

Interventions

Consumption of capsule/bread with vitamin D OTHER

A; B; C; D; E; F

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female adult who are free of any chronic disease
• Age 18-64 years
• BMI \<30kg/m2
• No medications or disorders that would affect vitamin D metabolism
• Women must be on birth control and not pregnant based on negative pregnancy test
• Ability and willingness to give informed consent and comply with protocol
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead

MeSH Terms

Interventions

Bread; Vitamin D

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02