Vitamin D in Vulnerable Adults (VIVA-VA)

Vitamin d Deficiency Clinical Trial

— VIVA-VA  

Official title:

Vitamin D in Vulnerable Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170273
• Other study ID #: F7574-R
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2010
• Last updated: January 13, 2015
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• male veterans

• 65 to 95 years of age

• independent

• sedentary

• vitamin D insufficiency

Exclusion Criteria:

• hypercalcemia

• renal failure

• living in a nursing home

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Frail Elderly
• Vitamin d Deficiency

Intervention

Dietary Supplement:
• vitamin D
cholecalciferol
• placebo
placebo tablet

Locations

Country	Name	City	State
United States	VA Medical Center, Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in lower extremity physical performance from baseline to 9 months		baseline and 9 months	No