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

NCT ID: NCT01691430

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-10-31

Brief Summary

Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.

Conditions

Bacteriuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

2 cranberry capsules

Experimental: 2 cranberry capsules

Group Type: ACTIVE_COMPARATOR

2 cranberry capsules

Intervention Type: DIETARY_SUPPLEMENT

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

2 placebo capsules

Experimental: 2 placebo capsules qd

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

2 cranberry capsules

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. female residents;

2. long term residents

3. English speaking; and

4. age ≥ 65 years.

Exclusion Criteria

1. residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);

2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;

3. residents with end stage renal disease on dialysis (they do not regularly produce urine);

4. residents unable to produce a baseline clean catch urine specimen for collection;

5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;

6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;

7. have an indwelling bladder catheter in place;

8. have an allergy to cranberry products;

9. are being treated with cranberry products;

10. residence <4 weeks.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Juthani-Mehta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Branford Hills Health Care

Branford, Connecticut, United States

Northbridge Health Care Center

Bridgeport, Connecticut, United States

Bridgeport Health Care Center

Bridgeport, Connecticut, United States

Bridgeport Manor

Bridgeport, Connecticut, United States

Riverside Health & Rehabilitation Center

East Hartford, Connecticut, United States

Ludlowe Health Care Center

Fairfield, Connecticut, United States

Glastonbury Health Care Center

Glastonbury, Connecticut, United States

The Nathaniel Witherell

Greenwich, Connecticut, United States

Arden House Care and Rehabilitation Center

Hamden, Connecticut, United States

Hamden Health Care Center

Hamden, Connecticut, United States

Avery Heights

Hartford, Connecticut, United States

Wadsworth Glen Health Care and Rehabilitation Center

Middletown, Connecticut, United States

Water's Edge Center for Health & Rehabilitation

Middletown, Connecticut, United States

Grimes Center

New Haven, Connecticut, United States

Mary Wade Home

New Haven, Connecticut, United States

Advanced Nursing & Rehab Center of New Haven

New Haven, Connecticut, United States

Shady Knoll Health Center

Seymour, Connecticut, United States

Lord Chamberlain Nursing & Rehabilitation Center

Stratford, Connecticut, United States

Village Green of Wallingford

Wallingford, Connecticut, United States

Abbott Terrace Health Center

Waterbury, Connecticut, United States

Hughes Health & Rehab Center

West Hartford, Connecticut, United States

Countries

United States

References

Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

Reference Type: DERIVED

PMID: 37947276 (View on PubMed)

Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

Reference Type: DERIVED

PMID: 37068952 (View on PubMed)

Datta R, Trentalange M, Van Ness PH, McGloin JM, Guralnik JM, Miller ME, Walkup MP, Nadkarni N, Pahor M, Gill TM, Quagliarello V, Juthani-Mehta M; LIFE Study Group. Serious adverse events of older adults in nursing home and community intervention trials. Contemp Clin Trials Commun. 2017 Dec 21;9:77-80. doi: 10.1016/j.conctc.2017.12.004. eCollection 2018 Mar.

Reference Type: DERIVED

PMID: 29696228 (View on PubMed)

Juthani-Mehta M, Van Ness PH, Bianco L, Rink A, Rubeck S, Ginter S, Argraves S, Charpentier P, Acampora D, Trentalange M, Quagliarello V, Peduzzi P. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1879-1887. doi: 10.1001/jama.2016.16141.

Reference Type: DERIVED

PMID: 27787564 (View on PubMed)

Other Identifiers

2P30AG021342-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AG041153-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1112009472

Identifier Type: -

Identifier Source: org_study_id