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

P

Pontificia Universidad Catolica de Chile

Status

Completed

Conditions

Vitamin D Deficiency

Treatments

Dietary Supplement: cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT02930434
RT_28-15 (Other Identifier)
15-148

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

Under 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Standard daily vitamin D3
Active Comparator group
Description:
Cholecalciferol 600 IU daily during one year or exit from Antarctica.
Treatment:
Dietary Supplement: cholecalciferol
Higher weekly vitamin D3
Active Comparator group
Description:
Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.
Treatment:
Dietary Supplement: cholecalciferol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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