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Vitamin D in Vulnerable Adults (VIVA-VA)

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VA Office of Research and Development

Status and phase

Completed
Phase 3

Conditions

Vitamin d Deficiency
Frail Elderly

Treatments

Dietary Supplement: placebo
Dietary Supplement: vitamin D

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01170273
F7574-R

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

Male

Ages

65 to 95 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 2 patient groups, including a placebo group

Placebo Arm
Placebo Comparator group
Description:
placebo capsule
Treatment:
Dietary Supplement: placebo
Cholecalciferol 4000 IU
Experimental group
Description:
cholecalciferol 4000 IU daily
Treatment:
Dietary Supplement: vitamin D

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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