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Vitamin D in Vulnerable Adults (VIVA-VA) (VIVA-VA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170273
First Posted: July 27, 2010
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: May 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Frail Elderly
Vitamin d Deficiency
Interventions: Dietary Supplement: vitamin D
Dietary Supplement: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Arm

placebo capsule

placebo: placebo tablet

participants received one daily tablet containing placebo for 9 months

Cholecalciferol 4000 IU

cholecalciferol 4000 IU daily

vitamin D: cholecalciferol

participants received one daily tablet containing cholecalciferol 4000 IU for 9 months


Participant Flow:   Overall Study
    Placebo Arm   Cholecalciferol 4000 IU
STARTED   64   66 
COMPLETED   56   57 
NOT COMPLETED   8   9 
Lost to Follow-up                6                8 
Protocol Violation                1                0 
Death                1                0 
Adverse Event                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Arm

placebo capsule

placebo: placebo tablet

participants received one daily tablet containing placebo for 9 months

Cholecalciferol 4000 IU

cholecalciferol 4000 IU daily

vitamin D: cholecalciferol

participants received one daily tablet containing cholecalciferol 4000 IU for 9 months

Total Total of all reporting groups

Baseline Measures
   Placebo Arm   Cholecalciferol 4000 IU   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   66   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.0  (7.3)   71.8  (6.3)   72.4  (6.8) 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      64 100.0%      66 100.0%      130 100.0% 


  Outcome Measures

1.  Primary:   Change in Short Physical Performance Battery Test Score   [ Time Frame: baseline and 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Silvina Levis MD
Organization: Miami VA Medical Center
phone: 305-575-3388
e-mail: silvina.levis-dusseau@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01170273     History of Changes
Other Study ID Numbers: F7574-R
First Submitted: July 22, 2010
First Posted: July 27, 2010
Results First Submitted: May 17, 2016
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016