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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, cholecalciferol, Antarctica, Chile, cathelicidin, bone metabolism, cardiovascular risk

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Standard daily vitamin D3

    Higher weekly vitamin D3

    Arm Description

    Cholecalciferol 600 IU daily during one year or exit from Antarctica.

    Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.

    Outcomes

    Primary Outcome Measures

    Change in serum 25-hydroxyvitamin D concentration
    In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.

    Secondary Outcome Measures

    sun exposure
    questionnaires
    sleep pattern
    questionnaires
    food intake of VD
    Food frequency questionnaire
    serum biomarkers for bone metabolism
    intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein
    serum high-sensitivity C-reactive protein (hsCRP)
    serum cathelicidin (LL-37) concentration

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    March 11, 2018
    Sponsor
    Pontificia Universidad Catolica de Chile
    Collaborators
    Fuerza Aérea de Chile, Instituto Antártico Chileno, Harvard Medical School (HMS and HSDM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02930434
    Brief Title
    Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
    Acronym
    AntarD
    Official Title
    Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 10, 2017 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pontificia Universidad Catolica de Chile
    Collaborators
    Fuerza Aérea de Chile, Instituto Antártico Chileno, Harvard Medical School (HMS and HSDM)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency
    Keywords
    Vitamin D, cholecalciferol, Antarctica, Chile, cathelicidin, bone metabolism, cardiovascular risk

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard daily vitamin D3
    Arm Type
    Active Comparator
    Arm Description
    Cholecalciferol 600 IU daily during one year or exit from Antarctica.
    Arm Title
    Higher weekly vitamin D3
    Arm Type
    Active Comparator
    Arm Description
    Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cholecalciferol
    Other Intervention Name(s)
    Vitamin D3
    Intervention Description
    Administration of vitamin D3
    Primary Outcome Measure Information:
    Title
    Change in serum 25-hydroxyvitamin D concentration
    Description
    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 Outcome Measure Information:
    Title
    sun exposure
    Description
    questionnaires
    Time Frame
    at 0, 6, 12 months of Antarctic residency
    Title
    sleep pattern
    Description
    questionnaires
    Time Frame
    at 0, 6, 12 months of Antarctic residency
    Title
    food intake of VD
    Description
    Food frequency questionnaire
    Time Frame
    at 0, 6, 12 months of Antarctic residency
    Title
    serum biomarkers for bone metabolism
    Description
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arturo Borzutzky, M.D.
    Organizational Affiliation
    School of Medicine, Pontificia Universidad Católica de Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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