- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780247
Environmental Influences on Vitamin D Status (Alaska/Hawaii)
Study Overview
Status
Conditions
Detailed Description
Purpose of the study: To determine the effect of environmental influences on Vitamin D status.
Specific Aims
- To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes (Alaska and Hawaii).
- To collect information on variables that influence Vitamin D status such as skin color, history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements used, and BMI.
- To collect typical food samples from the region for future analysis of their Vitamin D and 25D content.
- To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Alaska
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Anchorage, Alaska, United States, 99508
- Alaska Kidney and Diabetes Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Age of Subjects: The subjects will be between ages 18-60. The upper age is limited to age 60 as aging skin is less able to make vitamin D, therefore a separate study of elderly people would be more appropriate.
Racial and Ethnic Origin: Both sites have a diverse ethnic and racial population and the subjects will be as representative of the population as possible.
Description
Inclusion Criteria:
- Able to consent and come for a study visit. Male or female males and females ages 18-60.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Alaska residents
50 "healthy" community dwelling males or females.
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Hawaiian residents
50 "healthy" community dwelling males or females at each site
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes
Time Frame: crosssectional
|
crosssectional
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2. To collect information on variables that influence Vitamin D status such to collect information on skin color, history of sun exposure and sunscreen use, diet history, vitamin and calcium supplements used, and BMI.
Time Frame: cross sectional
|
cross sectional
|
To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).
Time Frame: cross sectional
|
cross sectional
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura A Armas, MD, Creighton University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Creighton6
- WIRB approval 20080712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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