Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants

Pontificia Universidad Catolica de Chile75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vitamin D Deficiency

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Administration of vitamin D3

Eligibility

Sex: ALLMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in serum 25-hydroxyvitamin D concentration

In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.

Time frame: at end of Antarctic residency or 1 year (90-365 days), whichever came first

Secondary Outcomes

sun exposure

questionnaires

Time frame: at 0, 6, 12 months of Antarctic residency

sleep pattern

questionnaires

Time frame: at 0, 6, 12 months of Antarctic residency

food intake of VD

Food frequency questionnaire

Time frame: at 0, 6, 12 months of Antarctic residency

serum biomarkers for bone metabolism

intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein

Time frame: 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

serum high-sensitivity C-reactive protein (hsCRP)

Time frame: 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

serum cathelicidin (LL-37) concentration

Time frame: 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

Data from ClinicalTrials.gov

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