Study Start Date: 01/01/2007
Study End Date: 12/31/2007

Evaluation of a Potential Treatment for Calcium Oxalate Urolithiasis in Dogs: Influence of an Orally-Administered Proposed Solution on 24-hour Urinary Saturation with Calcium Oxalate in Calcium Oxalate Urolith-forming Dogs

The objectives of this study are to evaluate a potential pharmacological treatment on risk of calcium oxalate stone formation. The hypothesis is that the treatment will help reduce the risk of calcium oxalate urolithiasis.

We are looking for dogs that have had calcium oxalate stones in order to evaluate the influence of a novel treatment on urinary risk for calcium oxalate stone formation. Dogs will either receive the study medication or a placebo for 2 weeks at which time 24-hour urine samples and blood samples will be collected for determination of urinary risk of calcium oxalate formation. Following a 1-week washout period, dogs will then receive the other treatment, either study medication or placebo, for an additional 2 weeks and samples will be collected again.

Study Design:

Prospective, Cross-over, Randomized, Double-blinded.

Sample Size:
12 dogs

Inclusion criteria:

1. Male and female dogs with a history of calcium oxalate stones, but otherwise healthy.
2. Owners must be willing and able to visit The University of Tennessee 3 times over a 5 week period, be willing and able to administer the study medication or placebo to their dog, and be willing to allow their dog to be hospitalized for a 24-hour period.

Exclusion Criteria:

1. Dogs will be excluded from the study if they received glucocorticoids, diuretics, or supplements containing calcium or vitamin D within the past 2 years, if they have other diseases that preclude feeding these diets, and if they have hypercalcemia.
2. Dogs receiving medication for other diseases (e.g. antibiotics for skin disease or levothyroxine supplementation for hypothyroidism) may be included if the treatment is approved by the principal investigator.
3. Inability to administer the dog the medication or inability to return to The University of Tennessee.

Study Controls:
The study is a cross-over study where dogs serve as their own controls.

Study Endpoints:
Dogs will receive study medication and placebo for two weeks each, and at the end of each two week period, 24-hour urine samples and blood samples will be collected.

Samples:
No samples will be submitted.

Costs/Reimbursements:
Cost of evaluations and treatments are covered by the project. Owners of dogs that complete the study will receive $100 for their time and travel.

Full Disclosure information:

• The study is funded by a grant from Lloyd Inc.
• The investigator has presented Pet-food-company-sponsored lecture on urolithiasis.
• The study will be published if results are negative.
• The study will be reported on VIN.
• The authors will acknowledge VIN if the study is published.
• Owners will need to sign an informed consent form.