Effects of Antarctic Environment on Vitamin D Status and... | NCT02930434

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

NCT02930434

Sponsor

Pontificia Universidad Catolica de Chile

Status

Completed

Last Update Posted

Mar 13, 2018Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

cholecalciferol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RT_28-15	Other Identifier	Instituto Antártico Chileno

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Dec 10, 2017Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Oct 10, 2016

First Submission Date that Met QC Criteria

Oct 10, 2016

First Posted Date

Oct 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2018

Last Update Posted Date

Mar 13, 2018Actual

Name	Class
Fuerza Aérea de Chile	OTHER_GOV
Instituto Antártico Chileno	UNKNOWN
Harvard Medical School (HMS and HSDM)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecalciferol	Dietary Supplement	Administration of vitamin D3	Higher weekly vitamin D3 Standard daily vitamin D3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in serum 25-hydroxyvitamin D concentration	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 Outcomes

Measure	Description	Time Frame
sun exposure	questionnaires	at 0, 6, 12 months of Antarctic residency
sleep pattern	questionnaires	at 0, 6, 12 months of Antarctic residency

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arturo Borzutzky, M.D.	School of Medicine, Pontificia Universidad Católica de Chile	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided