Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents

Yale University

Status and phase: Completed; Phase 1

Conditions: Bacteriuria

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cranberry Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01033383

UL1RR024139 (U.S. NIH Grant/Contract)

KL2RR024138 (U.S. NIH Grant/Contract)

0908005581

K23AG028691-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.

Full description

Each subject was enrolled after providing a baseline urine specimen. Cranberry/placebo capsules were consumed for 30 days. Urine specimens were obtained weekly for 4 weeks.

Enrollment: 80 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female nursing home residents 65 years of age or older with history of urinary tract infection within the past year.

Exclusion criteria

• 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]);
• residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
• residents with end stage renal disease on dialysis (they do not regularly produce urine);
• residents unable to produce a baseline clean catch urine specimen for collection;
• residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
• residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

3 placebo capsules

Placebo Comparator group

Description:

3 placebo capsules qd

Treatment:

Dietary Supplement: Placebo

1 cranberry capsule & 2 placebo capsules

Experimental group

Description:

1 active cranberry capsule and 2 placebo capsules qd

Treatment:

Dietary Supplement: Cranberry Capsule

Dietary Supplement: Placebo

2 cranberry capsules & 1 placebo capsule

Experimental group

Description:

2 active cranberry capsules and 1 placebo capsules qd

Treatment:

Dietary Supplement: Cranberry Capsule

Dietary Supplement: Placebo

3 cranberry capsules

Experimental group

Description:

3 active cranberry capsules qd

Treatment:

Dietary Supplement: Cranberry Capsule