Vitamin D DeficiencyAntarDNCT02930434
Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
A study testing cholecalciferol in people with Vitamin D Deficiency, run by Pontificia Universidad Catolica de Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- population of all ages living in the Chilean Antarctic territory during at least 3 months.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol
- Keywords
- Vitamin D, cholecalciferol, Antarctica, Chile, cathelicidin, bone metabolism, cardiovascular risk
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called Vitamin D3
Administration of vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Standard daily vitamin D3 | Active comparator | Cholecalciferol 600 IU daily during one year or exit from Antarctica. Receives: Dietary Supplement: cholecalciferol |
| Higher weekly vitamin D3 | Active comparator | Cholecalciferol 25000 IU once weekly during one year or exit from Antarctica. Receives: Dietary Supplement: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum 25-hydroxyvitamin D concentration
In Antarctic inhabitants not supplemented with VD that exit Antarctica before start of RCT phase of study.
Measured: at end of Antarctic residency or 1 year (90-365 days), whichever came first
Secondary outcomes (6)
sun exposure
questionnaires
Measured: at 0, 6, 12 months of Antarctic residency
sleep pattern
questionnaires
Measured: at 0, 6, 12 months of Antarctic residency
food intake of VD
Food frequency questionnaire
Measured: at 0, 6, 12 months of Antarctic residency
serum biomarkers for bone metabolism
intact PTH, calcium phosphorus, alkaline phosphatases, VD-binding protein
Measured: 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)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion10 Dec 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fuerza Aérea de Chile, Instituto Antártico Chileno, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Arturo Borzutzky, M.D., Principal investigator, School of Medicine, Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930434
- Sponsor's protocol ID
- 15-148
- Other IDs
- RT_28-15
- Acronym
- AntarD
- Status last verified
- Mar 2018
- First submitted
- 10 Oct 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants
- ClinicalTrials.gov ID
- NCT02930434
- Acronym / sponsor ID
- AntarD / 15-148
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, cholecalciferol, Antarctica, Chile, cathelicidin, bone metabolism, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fuerza Aérea de Chile, Instituto Antártico Chileno, Harvard Medical School (HMS and HSDM)
- Study start
- Oct 2016
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard daily vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolCholecalciferol 600 IU daily during one year or exit from Antarctica. |
| Higher weekly vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolCholecalciferol 25000 IU once weekly during one year or exit from Antarctica. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- population of all ages living in the Chilean Antarctic territory during at least 3 months.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: Vitamin D3Administration of vitamin D3 | Dietary supplement | Higher weekly vitamin D3, Standard daily vitamin D3 |
Primary outcome
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.
6 secondary outcomes
sun exposure
Time frame: at 0, 6, 12 months of Antarctic residency
sleep pattern
Time frame: at 0, 6, 12 months of Antarctic residency
food intake of VD
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Borzutzky, M.D. principal investigator
School of Medicine, Pontificia Universidad Católica de Chile
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Vitamin D Deficiency, run by Pontificia Universidad Catolica de Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum 25-hydroxyvitamin D concentration (time frame: at end of Antarctic residency or 1 year (90-365 days), whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.