Clinical trial NCT02930434: Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
Official title: Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
cholecalciferol
Antarctica
Chile
cathelicidin
bone metabolism
cardiovascular risk
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Fuerza Aérea de Chile
name: Instituto Antártico Chileno
name: Harvard Medical School (HMS and HSDM)
First posted: 2016-10-12
Enrollment: 75
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health risk in the inhabitants of Chilean Antarctica.

Detailed description: The present study consists of an initial cross-sectional evaluation of VD status and specific health biomarkers in inhabitants of Chilean Antarctica, followed by a randomized controlled trial evaluating two acceptable approaches of vitamin D supplementation (cholecalciferol 600 IU daily vs. 25000 IU weekly) in Antarctic inhabitants.

Eligibility criteria: Inclusion Criteria:

* population of all ages living in the Chilean Antarctic territory during at least 3 months.

Exclusion Criteria:

* acute or chronic renal disease
* hyper or hypocalcemia
* osteomalacia or Paget's disease of bone
* use of VD supplements or fish oil supplements in the past month in doses higher than 400 IU daily
* treatment for known VD deficiency in the last 6 months
* UV phototherapy in the past month.

Primary outcomes:
measure: Change in serum 25-hydroxyvitamin D concentration
timeFrame: at end of Antarctic residency or 1 year (90-365 days), whichever came first
Secondary outcomes:
measure: sun exposure
timeFrame: at 0, 6, 12 months of Antarctic residency
measure: sleep pattern
timeFrame: at 0, 6, 12 months of Antarctic residency
measure: food intake of VD
timeFrame: at 0, 6, 12 months of Antarctic residency
measure: serum biomarkers for bone metabolism
timeFrame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
measure: serum high-sensitivity C-reactive protein (hsCRP)
timeFrame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
measure: serum cathelicidin (LL-37) concentration
timeFrame: at baseline and every 3 months during supplementation (3,6,9,12 months) up to end of Antarctic residency or 1 year (90-365 days), whichever came first
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Arturo Borzutzky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: