Environmental Influences on Vitamin D Status (Alaska/Hawaii)

October 24, 2008 updated by: Creighton University
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. However, the relative influences of each are largely unknown and we cannot reliably answer the question of how much sun exposure an individual needs at various latitudes and at various seasons in order to ensure normal vitamin D status.

Study Overview

Status

Completed

Detailed Description

Purpose of the study: To determine the effect of environmental influences on Vitamin D status.

Specific Aims

  1. To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes (Alaska and Hawaii).
  2. 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.
  3. To collect typical food samples from the region for future analysis of their Vitamin D and 25D content.
  4. 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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Kidney and Diabetes Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alaska residents
50 "healthy" community dwelling males or females.
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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Laura A Armas, MD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

October 24, 2008

First Posted (Estimate)

October 27, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2008

Last Update Submitted That Met QC Criteria

October 24, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

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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