Evaluation of Vitamin K Supplementation for Calcific Uremic Arteriolopathy

Completed · Not applicable · Has a placebo group

Conditions studied: Calciphylaxis, Calcific Uremic Arteriolopathy

In brief

Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and significant morbidity associated with non-healing and extremely painful skin lesions. At present, there is no effective treatment for calcific uremic arteriolopathy. Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of vascular calcification. However, the effects of vitamin K supplementation in patients with calcific uremic arteriolopathy are unknown. The purpose of this study is to conduct a pilot randomized controlled trial to examine the effects of oral vitamin K supplementation on circulating levels of anti-calcification factor (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic arteriolopathy.

Key facts

Study ID

NCT02278692

Run by

Massachusetts General Hospital

People needed

26

Starts

2015-03-01

Expected to finish

2019-08-01

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Calcific uremic arteriolopathy (a.k.a. calciphylaxis)

You may not qualify if…

• Warfarin discontinuation contra-indicated (e.g. mechanical heart valve)
• Prior allergic reaction to vitamin K
• Prior history of venous thromboembolism*
• Pregnancy and lactation
• (*Patients with prior history of thrombosis who are treated with non-warfarin anticoagulant agents (e.g. apixaban, enoxaparin, etc) will be considered for inclusion)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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