Clinical trial NCT00780247: Environmental Influences on Vitamin D Status
Official title: Environmental Influences on Vitamin D Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Sun
Latitude
Vitamin D status
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2008-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes
timeFrame: crosssectional
Secondary outcomes:
measure: 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.
timeFrame: cross sectional
measure: To collect a blood sample for DNA analysis of inter-individual differences in Vitamin D metabolism (Gc or Vitamin D binding protein alleles).
timeFrame: cross sectional
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Kidney and Diabetes Associates
state: Alaska
Study officials:
affiliation: Creighton University
name: Laura A Armas, MD
role: PRINCIPAL_INVESTIGATOR
References: