HealthyNCT02720575
Evaluation of the Bioavailability of Vitamin D2 in Yeast and Bread
A study testing Consumption of capsule/bread with vitamin D in people with Healthy, run by Boston University.
Trial summary
The objective of this study is to test the bioavailability of vitamin D in bread. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Consumption of capsule/bread with vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
The objective of this study is to test the bioavailability of vitamin D in bread.
Read the 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
- Being tested
- Consumption of capsule/bread with vitamin D
- Keywords
- Vitamin D, Bioavailability, Fortified Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of capsule/bread with vitamin DOther
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 50,000 IU of crystalline D2 in 5 capsules.. Vitamin D2 in its natural state consumed orally via capsule Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Consumption of capsule/bread with vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the fist 24, 48, 72, 96, and 144 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael F. Holick, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720575
- Sponsor's protocol ID
- H-833963
- Status last verified
- Feb 2017
- First submitted
- 22 Mar 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioavailability of Vitamin D2 in Yeast and Bread
- ClinicalTrials.gov ID
- NCT02720575
- Acronym / sponsor ID
- H-833963
- Conditions
- Healthy
- Keywords
- Vitamin D, Bioavailability, Fortified Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Mar 2016 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Consumption of capsule/bread with vitamin D50,000 IU of crystalline D2 in 5 capsules.. Vitamin D2 in its natural state consumed orally via capsule |
| B | Active comparator | Other: Consumption of capsule/bread with vitamin D50,000 IU of crystalline D3 in 5 capsules.. Vitamin D3 in its natural state consumed orally via capsule |
| C | Active comparator | Other: Consumption of capsule/bread with vitamin D50,000 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. |
| D | Active comparator | Other: Consumption of capsule/bread with vitamin D50,000 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. |
| E | Experimental | Other: Consumption of capsule/bread with vitamin D50,000 IU of vitamin D2 from 2 slices of bread made from bread. Bread raised with yeast rich in vitamin D. Main experimental arm. |
| F | Experimental | Other: Consumption of capsule/bread with vitamin D50,000 IU of vitamin D2 from 2 slices of bread. Bread raised with yeast and yeast cell walls rich in vitamin D. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Consumption of capsule/bread with vitamin D | Other | A, B, C, D, E, F |
Primary outcome
Evidence of serum vitamin D levels proceeding ingestion of bread raised with yeast containing vitamin D
Time frame: within the fist 24, 48, 72, 96, and 144 hours after ingestion
The subject blood will be monitored at the above mentioned time frame after consuming vitamin D in capsular or bread form.
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 28 Feb 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of capsule/bread with vitamin D in people with Healthy, run by Boston University.
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 7 inclusion and 2 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Evidence of serum vitamin D levels proceeding ingestion of bread raised with yeast containing vitamin D (time frame: within the fist 24, 48, 72, 96, and 144 hours after ingestion). 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 28 Feb 2017.