Therapeutic Focus

Vitamin D Insufficiency

Vitamin D hormone production declines markedly if the pro-hormone, 25-hydroxyvitamin D, is in short supply, a condition often described by terms such as “vitamin D insufficiency”. Therefore, measurement of 25-hydroxyvitamin D levels in blood has become the accepted method among healthcare professionals to monitor vitamin D status.

Vitamin D insufficiency is nearly ubiquitous in the chronic kidney disease (CKD) population.  Recent studies have documented that the great majority of CKD patients have low blood levels of 25-hydroxyvitamin D, suggesting that the onset of CKD is a significant risk factor for vitamin D insufficiency and that the prevalence of vitamin D insufficiency increases as CKD progresses.  In addition, recent studies have linked vitamin D insufficiency to progression of CKD and increased morbidity and mortality in hemodialysis patients.

U.S. Market Opportunity

Vitamin D insufficiency has been shown to exacerbate the development of secondary hyperparathyroidism (SHPT) and related bone diseases (e.g., renal osteodystrophy). Published sources indicate that approximately 70% of Stage 3, 80% of Stage 4, and 90% of Stage 5 patients suffer from vitamin D insufficiency. There are approximately 12 million Stage 3 and 4 CKD patients, and over 500,000 Stage 5 patients in the U.S.

Parallel advances in the understanding of vitamin D insufficiency and its complications have resulted in a global initiative known as Kidney Disease: Improving Global Outcomes (KDIGO). The guidelines from KDIGO advocate the treatment of vitamin D insufficiency in CKD patients with SHPT.

Currently in the U.S., there are only two options available for the prevention and treatment of vitamin D insufficiency: over-the-counter (OTC) dietary supplements which typically contain 400 to 5,000 IU per unit dose of either vitamin D2 or D3, and prescription oral products containing 50,000 IU per unit dose of vitamin D2. Recent studies have shown that both options have limited efficacy in restoring adequate vitamin D pro-hormone level, especially in patients who are overweight.


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