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Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

This study has been completed.
Sponsor:
Collaborator:
NSA, Collierville, TN, USA
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00778648
First received: October 21, 2008
Last updated: September 9, 2010
Last verified: September 2010
Results First Received: September 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Common Cold
Interventions: Dietary Supplement: Juice Plus
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
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Reporting Groups
  Description
Juice Plus No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Juice Plus     Placebo  
STARTED     272     271  
COMPLETED     263     266  
NOT COMPLETED     9     5  



  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.
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Reporting Groups
  Description
Juice Plus No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Juice Plus     Placebo     Total  
Number of Participants  
[units: participants]
  272     271     543  
Age  
[units: years]
Mean ± Standard Deviation
  40.9  ± 10.2     38.8  ± 10.3     40.9  ± 10.2  
Gender  
[units: participants]
     
Female     202     222     424  
Male     61     44     105  
Region of Enrollment  
[units: participants]
     
Germany     272     271     543  



  Outcome Measures

1.  Primary:   Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.   [ Time Frame: within 6 months (after 2 months run-in period) ]

2.  Secondary:   Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs   [ Time Frame: Baseline, months 2,4,6,8. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
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:  
Name/Title: Dr. Stephanie Roll
Organization: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie , Charité - Universitätsmedizin Berlin, Germany
phone: +49 30 450 529023
e-mail: stephanie.roll@charite.de


Publications:

Responsible Party: Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center
ClinicalTrials.gov Identifier: NCT00778648     History of Changes
Other Study ID Numbers: JPCC
Study First Received: October 21, 2008
Results First Received: September 9, 2010
Last Updated: September 9, 2010
Health Authority: Germany: Ethics Commission