NCT00780247

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

Enrollment Period

1 month

First QC Date

October 24, 2008

Last Update Submit

October 24, 2008

Conditions

Keywords

Vitamin DSunLatitudeVitamin D status

Outcome Measures

Primary Outcomes (1)

  • To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes

    crosssectional

Secondary Outcomes (2)

  • 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.

    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).

    cross sectional

Study Arms (2)

Alaska residents

50 "healthy" community dwelling males or females.

Hawaiian residents

50 "healthy" community dwelling males or females at each site

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Able to consent and come for a study visit. Male or female males and females ages 18-60.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Kidney and Diabetes Associates

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Laura A Armas, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations