Vitamin D DeficiencyNCT01443897
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
A study testing 1,000 IU vitamin D2, mushrooms and UVB-treated mushrooms, 400 IU vitamin D2 in people with Vitamin D Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 1,000 IU vitamin D2, mushrooms and UVB-treated mushrooms, 400 IU vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2011
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing to consume a lunch meal 7 days per week for 6 weeks containing mushrooms
- willing to stop eating other sources of mushrooms
- willing to discontinue taking vitamin D and other dietary supplements
- estimated low vitamin D status based on dietary questionnaire, skin reflectance, and sun behavior
Who cannot join
- women who are pregnant or breastfeeding
- volunteers with anemia
- volunteers with evidence of underlying disease affecting vitamin D metabolism
- volunteers taking medications altering vitamin D metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.
Read the detailed description
Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.
- Conditions
- Vitamin D Deficiency
- Being tested
- 1,000 IU vitamin D2, placebo capsule, mushrooms, UVB-treated mushrooms, 400 IU vitamin D2, UVB-treated mushrooms, 1,000 IU vitamin D2
- Keywords
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,000 IU vitamin D2Dietary supplement
capsule containing 1,000 IU vitamin D2
placebo capsuleDietary supplement
0 IU vitamin D2
mushroomsOther
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated mushrooms, 400 IU vitamin D2Other
UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated mushrooms, 1,000 IU vitamin D2Other
UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Untreated mushrooms plus placebo capsule. Receives: Dietary Supplement: placebo capsule; Other: mushrooms |
| Group 2 | Experimental | UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule. Receives: Dietary Supplement: placebo capsule; Other: UVB-treated mushrooms, 400 IU vitamin D2 |
| Group 3 | Experimental | UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule. Receives: Dietary Supplement: placebo capsule; Other: UVB-treated mushrooms, 1,000 IU vitamin D2 |
| Group 4 | Experimental | Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule Receives: Dietary Supplement: 1,000 IU vitamin D2; Other: mushrooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Vitamin D2
Serum vitamin D 2 will be measured in serum.
Measured: 0, 3 and 6 weeks
Secondary outcomes (1)
Change in serum markers of inflammation
Measure serum cytokines, chemokines, and neopterin.
Measured: 0, 3, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionJun 2011
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charles B Stephensen, PhD, Principal investigator, USDA, ARS, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443897
- Sponsor's protocol ID
- 201017924-1
- Status last verified
- Sep 2011
- First submitted
- 28 Sep 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
- ClinicalTrials.gov ID
- NCT01443897
- Acronym / sponsor ID
- 201017924-1
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Sep 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.
This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.
Detailed description
Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Dietary Supplement: placebo capsule, Other: mushroomsUntreated mushrooms plus placebo capsule. |
| Group 2 | Experimental | Dietary Supplement: placebo capsule, Other: UVB-treated mushrooms, 400 IU vitamin D2UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule. |
| Group 3 | Experimental | Dietary Supplement: placebo capsule, Other: UVB-treated mushrooms, 1,000 IU vitamin D2UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule. |
| Group 4 | Experimental | Dietary Supplement: 1,000 IU vitamin D2, Other: mushroomsUntreated mushrooms plus 1,000 IU Vitamin D2 in capsule |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- willing to consume a lunch meal 7 days per week for 6 weeks containing mushrooms
- willing to stop eating other sources of mushrooms
- willing to discontinue taking vitamin D and other dietary supplements
- estimated low vitamin D status based on dietary questionnaire, skin reflectance, and sun behavior
Key exclusion criteria (4 listed)
- women who are pregnant or breastfeeding
- volunteers with anemia
- volunteers with evidence of underlying disease affecting vitamin D metabolism
- volunteers taking medications altering vitamin D metabolism
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 |
|---|---|---|
| 1,000 IU vitamin D2capsule containing 1,000 IU vitamin D2 | Dietary supplement | Group 4 |
| placebo capsule0 IU vitamin D2 | Dietary supplement | Group 1, Group 2, Group 3 |
| mushroomsuntreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA | Other | Group 1, Group 4 |
| UVB-treated mushrooms, 400 IU vitamin D2UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA | Other | Group 2 |
| UVB-treated mushrooms, 1,000 IU vitamin D2UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA | Other | Group 3 |
Primary outcome
Change in serum Vitamin D2
Time frame: 0, 3 and 6 weeks
Serum vitamin D 2 will be measured in serum.
1 secondary outcome
Change in serum markers of inflammation
Time frame: 0, 3, and 6 weeks
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 30 Sep 2011.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
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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.
Charles B Stephensen, PhD principal investigator
USDA, ARS, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1,000 IU vitamin D2, mushrooms and UVB-treated mushrooms, 400 IU vitamin D2 in people with Vitamin D Deficiency, run by USDA, Western Human Nutrition Research Center 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 4 inclusion and 4 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 30 Sep 2011. 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. Some participants in this study may receive a placebo. 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?
Change in serum Vitamin D2 (time frame: 0, 3 and 6 weeks). 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 30 Sep 2011.