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A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents

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ClinicalTrials.gov Identifier: NCT01691430
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Bacteriuria
Interventions: Dietary Supplement: 2 cranberry capsules
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from nursing homes within 50 miles of New Haven.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
806 patients were eligible, 558 declined to participate. Of the 248 consented, 63 were found to be ineligible after consent, leaving 185 to randomize.

Reporting Groups
  Description
2 Cranberry Capsules

Experimental: 2 cranberry capsules

2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

2 Placebo Capsules

Experimental: 2 placebo capsules qd

Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)


Participant Flow:   Overall Study
    2 Cranberry Capsules   2 Placebo Capsules
STARTED   92   93 
Received Medication   92   93 
COMPLETED   70   73 
NOT COMPLETED   22   20 
Death                17                16 
Withdrawal by Subject                5                1 
Lost to Follow-up                0                3 



  Baseline Characteristics

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.
Inclusion criteria were (1) female; (2) long-term care residents; (3) English speaking; and (4) 65 years or older.

Reporting Groups
  Description
2 Cranberry Capsules

Experimental: 2 cranberry capsules

2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

2 Placebo Capsules

Experimental: 2 placebo capsules qd

Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

Total Total of all reporting groups

Baseline Measures
   2 Cranberry Capsules   2 Placebo Capsules   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   93   185 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      92 100.0%      93 100.0%      185 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      92 100.0%      93 100.0%      185 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   83   84   167 
Non-White   9   9   18 
Bacteriuria plus pyuria 
[Units: Participants]
 27   32   59 


  Outcome Measures

1.  Primary:   Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)   [ Time Frame: One year ]

2.  Secondary:   Number of Episodes of Symptomatic UTI   [ Time Frame: One year ]

3.  Secondary:   Number of Hospitalizations   [ Time Frame: One year ]

4.  Secondary:   Number of Deaths   [ Time Frame: One year ]

5.  Secondary:   Number of Antibiotic Prescriptions   [ Time Frame: One year ]

6.  Secondary:   Bacteriuria With Multidrug-resistant Gram-negative Bacilli   [ Time Frame: One year ]

7.  Secondary:   Number of Antibiotic Prescriptions for Suspected UTI   [ Time Frame: One Year ]

8.  Secondary:   Subjects With 1, 2, or 3 Episodes of UTIs   [ Time Frame: One year ]

9.  Other Pre-specified:   Number of Adverse Events in Participants   [ Time Frame: One year ]

10.  Other Pre-specified:   Adherence to Capsule Intake by All Participants   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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. Manisha Juthani-Mehta
Organization: Yale University
phone: (203)785-4140
e-mail: manisha.juthani@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691430     History of Changes
Other Study ID Numbers: 1112009472
First Submitted: August 9, 2012
First Posted: September 24, 2012
Results First Submitted: February 14, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018