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

March 11, 2018 updated by: Pontificia Universidad Catolica de Chile
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard daily vitamin D3
Cholecalciferol 600 IU daily during one year or exit from Antarctica.
Dietary supplement: cholecalciferol
Administration of vitamin D3
Other Names:
  • Vitamin D3
Active Comparator: Higher weekly vitamin D3
Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.
Dietary supplement: cholecalciferol
Administration of vitamin D3
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum 25-hydroxyvitamin D concentration
Time Frame: at end of Antarctic residency or 1 year (90-365 days), whichever came first
In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.
at end of Antarctic residency or 1 year (90-365 days), whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sun exposure
Time Frame: at 0, 6, 12 months of Antarctic residency
questionnaires
at 0, 6, 12 months of Antarctic residency
sleep pattern
Time Frame: at 0, 6, 12 months of Antarctic residency
questionnaires
at 0, 6, 12 months of Antarctic residency
food intake of VD
Time Frame: at 0, 6, 12 months of Antarctic residency
Food frequency questionnaire
at 0, 6, 12 months of Antarctic residency
serum biomarkers for bone metabolism
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
intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Harvard Medical School (HMS and HSDM)
Fuerza Aérea de Chile
Instituto Antártico Chileno

Investigators

  • Principal Investigator: Arturo Borzutzky, M.D., School of Medicine, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 10, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 11, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-148
  • RT_28-15 (Other Identifier: Instituto Antártico Chileno)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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