Vitamin D DeficiencyNCT01208636
Environmental & Genetic Influences on Vitamin D Status
An observational study of Vitamin D Deficiency, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2010
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include 50 "healthy" unrelated community dwelling males or females. The subjects will be between ages 18-60.
Who may be able to join
- Able to consent and come for a study visit.
- Male or female between ages 18-60.
- Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months.
Who cannot join
- Unable to consent or come to a visit
- Taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
- Related to another participant by blood.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status.
Read the detailed description
Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. Surprisingly, Vitamin D deficiency has been described in people dwelling in southern Florida and in surfers in Hawaii. We hypothesize that genetic variations in vitamin metabolism accounts for these differences.
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D deficiency, Sun, Genetics
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sun exposed people | Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D levels
25(OH)D levels were measured at the only visit
Measured: 1 month
Secondary outcomes (1)
Genetic testing of 13 candidate genes
13 candidate genes were tested and their relationship to 25(OH)D examined.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Investigators
- Laura Armas, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208636
- Sponsor's protocol ID
- Creighton9
- Status last verified
- Sep 2010
- First submitted
- 30 Aug 2010
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental & Genetic Influences on Vitamin D Status
- ClinicalTrials.gov ID
- NCT01208636
- Acronym / sponsor ID
- Creighton9
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D deficiency, Sun, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Aug 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Sep 2010 (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 purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status.
Detailed description
Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. Surprisingly, Vitamin D deficiency has been described in people dwelling in southern Florida and in surfers in Hawaii. We hypothesize that genetic variations in vitamin metabolism accounts for these differences.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sun exposed people | – | –Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include 50 "healthy" unrelated community dwelling males or females. The subjects will be between ages 18-60.
Key inclusion criteria (3 listed)
- Able to consent and come for a study visit.
- Male or female between ages 18-60.
- Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months.
Key exclusion criteria (3 listed)
- Unable to consent or come to a visit
- Taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
- Related to another participant by blood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
25(OH)D levels
Time frame: 1 month
25(OH)D levels were measured at the only visit
1 secondary outcome
Genetic testing of 13 candidate genes
Time frame: 1 month
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 24 Sep 2010.
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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.
Laura Armas, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Creighton University 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 3 inclusion and 3 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 24 Sep 2010. 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. 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?
25(OH)D levels (time frame: 1 month). 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 24 Sep 2010.