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

NCT02930434 | Completed

• 2 other identifiers: 15-148RT_28-15
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; cholecalciferol; Antarctica; Chile; cathelicidin; bone metabolism; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• sun exposure

  at 0, 6, 12 months of Antarctic residency

• sleep pattern

  at 0, 6, 12 months of Antarctic residency

• food intake of VD

  at 0, 6, 12 months of Antarctic residency

• serum biomarkers for bone metabolism

  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)

  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

Study Arms (2)

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

cholecalciferol DIETARY_SUPPLEMENT

Administration of vitamin D3

Also known as: Vitamin D3

Higher weekly vitamin D3; Standard daily vitamin D3

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• population of all ages living in the Chilean Antarctic territory during at least 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fuerza Aérea de Chile: collaborator
• Instituto Antártico Chileno: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Arturo Borzutzky, M.D.

  School of Medicine, Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: December 10, 2017
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03