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

Vitamin D Deficiency Clinical Trial

— AntarD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930434
• Other study ID #: 15-148
• Secondary ID: RT_28-15
• Status: Completed
• Phase: N/A
• First received: October 10, 2016
• Last updated: March 11, 2018
• Start date: October 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 1, 2018
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
Administration of vitamin D3

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Fuerza Aérea de Chile, Harvard Medical School, Instituto Antártico Chileno

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sun exposure	questionnaires	at 0, 6, 12 months of Antarctic residency
Secondary	sleep pattern	questionnaires	at 0, 6, 12 months of Antarctic residency
Secondary	food intake of VD	Food frequency questionnaire	at 0, 6, 12 months of Antarctic residency
Secondary	serum biomarkers for bone metabolism	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
Secondary	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
Secondary	serum cathelicidin (LL-37) concentration		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