Clinical Study Opportunity: Vitamin D Status in Cats with Primary Hepatobiliary Disease

Description:

The liver performs an essential role in the absorption of dietary vitamin D and synthesis of the active form of vitamin D. Vitamin D deficiency is a known problem in people with liver disease and these patients routinely receive supplementation. Vitamin D deficiency has not been documented in cats with liver disease. Our goal is to determine if cats with primary liver disease have low levels of vitamin D. If they do, this finding could lead to the development of clinical guidelines for vitamin D supplementation.

Inclusion Criteria:

Cats over one year of age with one of the following:

  • Hyperbilirubinemia
  • Elevated ALT and/or ALP
  • Cytologic or histopathologic diagnosis of a primary hepatobiliary disease

Exclusion Criteria:

  • Hyperthyroidism
  • Acute pancreatitis
  • IRIS Stage 2 chronic kidney disease (creatinine >1.6 mg/dl)
  • Congestive heart failure
  • Hypercalcemia (elevated ionized calcium)
  • Corticosteroid or ursodeoxycholic acid administration within the last two weeks

Client Benefits:

The study will cover the cost of the vitamin D panel. Your cat’s participation will also allow us to gain information that will help in the treatment of other cats with this condition

Contact information:

For questions regarding the clinical trial, please email the clinical trials technician, Diane Welsh at clinicaltrials@tufts.edu

Pets Benefit with Access to State-of-the-Art Research Studies

Background

Bolt, an eight-year-old German Shepherd was diagnosed in Fall 2012 with perianal fistulas. Anal fistulas are very common in this breed of dogs and can be extremely painful. Leading up to Bolt’s development of these fistulas, owner Paul Higgins describes Bolt’s long history of recurrent skin infections and was referred by his primary care veterinarian at Eastham Vets to a dermatology specialist at VCA in Weymouth. Dr. Loren Cohen was successful in managing Bolt’s skin conditions with cyclosporine; however, a couple years later he developed these anal fistulas, which were not resolving. Dr. Cohen had heard about a clinical trial that was being conducted at Cummings School of Veterinary Medicine at Tufts University to treat anal fistulas and suggested that owner Paul Higgins meet faculty member and principal investigator, Lluis Ferrer DVM, PhD, DECVD. Cummings School is a committed part of the One Health initiative that links the human, animal, environmental and research worlds together. “One of our missions is to offer trials that are on the cutting edge of medical advancement, for both animals and humans,” says Dr. Ferrer. Continue reading

Clinical Studies

As an academic veterinary medical center, the faculty and staff at Cummings School of Veterinary Medicine are constantly exploring new scientific breakthroughs through clinical research studies. These studies may involve the use of a new drug, a newly developed medical device, a new procedure, or a behavioral change, such as diet. With the potential to improve quality of life, clinical studies lead to diagnostics and treatments that clarify which therapeutic approaches work best for certain diseases or conditions, and have the potential to change the way we practice veterinary medicine.

Benefits of Participation

There are a number of benefits to having a client’s pet participate in a clinical study:

  • You are assured the animal will receive care from a highly specialized support team, who monitor the animal’s health very closely.
  • Some of the cost of participating in the clinical study including medications, blood tests and follow-up may be covered, easing the financial burden to the client.
  • The pet gains access to cutting-edge therapies that are not otherwise available, providing hope for owners, a better quality of life for the pet or even additional years to live.

Above all, many clients find a great sense of reward knowing that they are helping other animals and contributing to the advancement of veterinary medicine.

Strict Review and Protocols are in Place

Each trial is led by one principal investigator (PI), who may often be supported by several co-investigators providing the most comprehensive expertise. Currently there just over 70 clinical trials ongoing at Cummings School, all of which have a master plan called a protocol that has undergone rigorous evaluation by the School’s animal study review board known as the Clinical Science Review Board (CSRC).

After speaking to personnel with intimate knowledge of the protocol, and prior to entering their animal into a study, all clients must sign informed consent statements. This informed consent includes details about the treatments and tests their animal will receive and a summary of the benefits and risks.

Most often the clients will return to the Foster Hospital for follow-up care, although some clinical studies are so simple that they may only involve sampling at a single point in time. Since many therapies represent new treatment approaches, it is important that the animals adhere to strict protocol guidelines to minimize the possibility of side effects. Any new treatments may have side effects, some which may be anticipated or others that are not expected.

Clinical Trials Underway

Cummings School Clinical Trials Lab has a broad array of trials currently underway, some of which are exploring:

  • canine stem cells used to treat protein-losing enteropathy and protein-losing nephropathy
  • the role of anti-angiogenesis therapy in feline squamous cell carcinoma
  • the drug pimobendan in cats with chronic renal failure
  • metronomic chemotherapy in canine osteosarcoma

A comprehensive and updated list can be found at our clinical trial web site. Inclusion and exclusion criteria for each study are also specified so you can quickly determine if your patient might be eligible.

The Lab is staffed full-time by two registered veterinary technicians, Diane Welsh and Sarah Cass, who together have more than four decades of experience working with clinical patients.

The success of any clinical trial depends entirely on recruitment and enrollment of an appropriate population of patients. We look forward to working with you to bring your clients the most state-of-the-art and innovative therapies where standard medical protocols may often fall short. If you have any questions about a particular trial or your patient’s eligibility contact the Clinical Trials Labs by email at clinicaltrials@tufts.edu.

Evaluating hypercoagulability in dogs with brachycephalic airway syndrome: similarity to human obstructive sleep apnea.

The primary purpose of the study is to determine whether English Bulldogs are more hypercoagulable, (an abnormality of the clotting process that increases the risk of developing blood clots within blood vessels) than non-brachycephalic dogs by running a series of coagulation tests. We are also interested in determining if C-reactive protein, a marker of inflammation and cardiovascular risk, is elevated in English Bulldogs as it is in humans with obstructive sleep apnea.

For more information regarding this study please visit: http://sites.tufts.edu/vetclinicaltrials/