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Trial record 9 of 30 for:    high dose vitamin k

Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

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ClinicalTrials.gov Identifier: NCT01102374
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
The American Geriatrics Society
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Infection
Interventions Drug: High Dose Vitamin D
Drug: Standard Dose Vitamin D
Drug: Placebo
Dietary Supplement: Usual Care
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Period Title: Overall Study
Started 55 52
Completed 39 33
Not Completed 16 19
Reason Not Completed
Death             9             13
Lost to Follow-up             7             6
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D Total
Hide Arm/Group Description

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Total of all reporting groups
Overall Number of Baseline Participants 55 52 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 52 participants 107 participants
80  (10) 82  (10) 81  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 52 participants 107 participants
Female
33
  60.0%
29
  55.8%
62
  57.9%
Male
22
  40.0%
23
  44.2%
45
  42.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 52 participants 107 participants
55 52 107
25-hydroxyvitamin D level  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 55 participants 52 participants 107 participants
23.0  (8.4) 23.0  (9.9) 23.0  (9.1)
1.Primary Outcome
Title Number of Acute Respiratory Infections (ARIs)
Hide Description ARIs defined as upper or lower respiratory infections
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
32 48
2.Secondary Outcome
Title Severity of Acute Respiratory Infections
Hide Description ARIs resulting in emergency department visits or hospitalizations
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
3 6
3.Secondary Outcome
Title Time to First ARI
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: Hazard Ratio
0.59 1.00
4.Secondary Outcome
Title Change in 25-hydroxyvitamin D (25OHD) Level
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Mean (Standard Error)
Unit of Measure: ng/mL
8.18  (0.75) 2.71  (0.80)
5.Secondary Outcome
Title Change in Parathyroid Hormone Level
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Issue relating to sample collection/processing precluded measurement of PTH level in the trial
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Falls
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: Events
70 27
7.Secondary Outcome
Title Fractures
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
5 8
8.Secondary Outcome
Title Number of Upper Respiratory Infections
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
21 36
9.Secondary Outcome
Title Number of Lower Respiratory Infections
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
11 12
10.Secondary Outcome
Title Number of Influenza-like Illnesses
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
collected together with lower respiratory infections (not as a separate category)
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Incident Kidney Stones
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Incident Hypercalcemia
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Death
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Count of Participants
Unit of Measure: Participants
9
  16.4%
13
  25.0%
14.Secondary Outcome
Title Number of Urinary Tract Infections
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
38 22
15.Secondary Outcome
Title Number of Other Infections
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description:

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: events
33 43
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Vitamin D Standard Dose Vitamin D
Hide Arm/Group Description

100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.

High Dose Vitamin D: Vitamin D3 100,000 IU monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Standard Dose Vitamin D: Vitamin D 12,000 IU monthly

Placebo: Placebo monthly

Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

All-Cause Mortality
High Dose Vitamin D Standard Dose Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
High Dose Vitamin D Standard Dose Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/55 (16.36%)      13/52 (25.00%)    
General disorders     
Death   9/55 (16.36%)  9 13/52 (25.00%)  13
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Vitamin D Standard Dose Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/55 (96.36%)      49/52 (94.23%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders [1]  7/55 (12.73%)  4/52 (7.69%) 
Cardiac disorders     
Cardiac disorders [1]  15/55 (27.27%)  9/52 (17.31%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders [1]  6/55 (10.91%)  1/52 (1.92%) 
Endocrine disorders     
Endocrine disorders [1]  3/55 (5.45%)  0/52 (0.00%) 
Eye disorders     
Eye disorders [1]  5/55 (9.09%)  7/52 (13.46%) 
Gastrointestinal disorders     
Gastrointestinal disorders [1]  22/55 (40.00%)  27/52 (51.92%) 
General disorders     
General disorders [1]  39/55 (70.91%)  28/52 (53.85%) 
Hepatobiliary disorders     
Hepatobiliary disorders [1]  1/55 (1.82%)  1/52 (1.92%) 
Immune system disorders     
Immune system disorders [1]  9/55 (16.36%)  7/52 (13.46%) 
Infections and infestations     
Infections and infestations [1]  21/55 (38.18%)  21/52 (40.38%) 
Injury, poisoning and procedural complications     
Injury, poisoning, and procedural complications [1]  29/55 (52.73%)  30/52 (57.69%) 
Investigations     
Investigations [1]  16/55 (29.09%)  12/52 (23.08%) 
Metabolism and nutrition disorders     
Metabolic and nutrition disorders [1]  18/55 (32.73%)  15/52 (28.85%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders [1]  17/55 (30.91%)  16/52 (30.77%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms [1]  1/55 (1.82%)  1/52 (1.92%) 
Nervous system disorders     
Nervous system disorders [1]  10/55 (18.18%)  10/52 (19.23%) 
Psychiatric disorders     
Psychiatric disorders [1]  30/55 (54.55%)  19/52 (36.54%) 
Renal and urinary disorders     
Renal and urinary disorders [1]  13/55 (23.64%)  10/52 (19.23%) 
Reproductive system and breast disorders     
Reproductive system disorders [1]  6/55 (10.91%)  2/52 (3.85%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic, and mediastinal disorders [1]  24/55 (43.64%)  30/52 (57.69%) 
Skin and subcutaneous tissue disorders     
Skin and subcutaneous disorders [1]  23/55 (41.82%)  22/52 (42.31%) 
Social circumstances     
Social circumstances [1]  1/55 (1.82%)  0/52 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures [1]  14/55 (25.45%)  6/52 (11.54%) 
[1]
Adverse events were recorded at the organ system level using the MedDRA classification system
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adit Ginde, MD, MPH, Professor of Emergency Medicine
Organization: University of Colorado School of Medicine
Phone: 720-848-6777
EMail: adit.ginde@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01102374    
Other Study ID Numbers: 09-0899
IND 106541 ( Other Identifier: FDA )
K23AG040708 ( U.S. NIH Grant/Contract )
First Submitted: April 11, 2010
First Posted: April 13, 2010
Results First Submitted: October 28, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017