Vitamin D in Vulnerable Adults (VIVA-VA)

Phase 3

Completed

• Conditions: Vitamin d Deficiency; Frail Elderly
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: placebo

• Registration Number: NCT01170273
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-27
• Study Start: 2010-08
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Results First Submitted: 2016-05-17
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-28
• Results First Posted: 2016-12-21
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

• male veterans
• 65 to 95 years of age
• independent
• sedentary
• vitamin D insufficiency

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Exclusion Criteria

• hypercalcemia
• renal failure
• living in a nursing home

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol 4000 IU	vitamin D	cholecalciferol 4000 IU daily
Placebo Arm	placebo	placebo capsule

Primary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery Test Score	baseline and 9 months	The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.

Trial Locations

Locations (1)

VA Medical Center, Miami; 🇺🇸 Miami, Florida, United States