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OpenTrials
Completed

NCT Number: NCT01170273

Vitamin D in Vulnerable Adults (VIVA-VA)

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.

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Key information

Conditions

Frail Elderly Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

65 year–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

cholecalciferol

Placebo

Dietary Supplement

placebo tablet

Primary outcomes

  1. Change in Short Physical Performance Battery Test Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Vitamin D in Vulnerable Adults

Acronym: VIVA-VA

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 27, 2010
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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