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Purpose and Brief Explanation of Study:
In people, hypovitaminosis D has been shown to be a negative prognostic factor associated with disease progression, development of renal secondary hyperparathyroidism, and mortality. We are currently investigating this relationship in dogs with chronic kidney disease (CKD).
It has yet to be investigated if supplementation with some form of vitamin D can improve vitamin D status and/or if this will have a positive effect on disease progression and survival.
Objective of the trial:
The purpose of this study is to determine how supplementation with vitamin D affects serum concentration and parathyroid hormone (PTH) concentrations in dogs with chronic kidney disease (CKD).
What qualifies my dog for enrollment in this in this trial?
To participate in this clinical trial your dog must:
- Be diagnosed with CKD, specifically International Renal Interest Society (IRIS) stage 2 or 3, which is based predominantly on serum creatinine.
- Be at least one year of age and weigh at least 10 kg (22 pounds).
- Have a serum 25(OH)D concentration < 70 ng/ml and a serum ionized calcium < 5.8 mg/dl.
- Not have a urine protein:creatinine (UPC) ratio > 2.0.
- Not be diagnosed with any other disease known to affect vitamin D or PTH concentrations (e.g., protein-losing enteropathy, primary hyperparathyroidism, primary hypoparathyroidism, hyperadrenocorticism).
- Not have cancer.
What does enrolling my dog in this clinical trial involve?
First your dog will have a physical examination and blood pressure measurement. Then your dog will have blood and urine collected to evaluate his/her suitability for enrollment. This will include a complete blood count (CBC), serum biochemistry profile, ionized calcium, urinalysis, urine protein:creatinine (UPC) ratio and serum 25(OH)D concentration.
If your dog meets the enrollment criteria, then your dog will receive a vitamin D (25[OH]D) supplement to be dosed once daily by mouth. Your dog must return for recheck examinations monthly for 3 months, at which time complete physical examinations and blood pressure measurements will be performed. Blood and urine will be collected.
After the first month, based your dog’s response to the supplement, we will determine if the dose requires adjustment. If so, your dog will need to return for one additional recheck visit (4 months after enrolment).
The study will cover over $3000 of appointment fees and diagnostic tests (including vitamin D metabolite, ionized calcium, and parathyroid hormone concentrations, as well as biochemistry profiles) over the study period. You will also receive a $500 credit to your OSU-VMC account to be used at your discretion.