Urea for Chronic Hyponatremia Study

STUDY BASICS

Are you an adult who has chronic low blood sodium levels (also called hyponatremia)? You may be able to participate in a research study to find out if a dietary supplement called Urea is a safe and effective treatment for people who have chronic hyponatremia. Compensation and parking provided.

STUDY PURPOSE

Hyponatremia occurs when the concentration of sodium in the blood is abnormally low. People with chronic hyponatremia may experience a range of symptoms, including balance problems and brain fog. Medications and lifestyle changes can help manage chronic hyponatremia, but these interventions can have side effects and may be difficult for patients to follow.

The purpose of this research study is to find out if a dietary supplement called Urea is a safe and effective treatment for people who have chronic hyponatremia. Urea is considered to be investigational in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of hyponatremia. Researchers hope their findings lead to better ways to treat hyponatremia in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 18 and up
• Have low blood sodium levels (hyponatremia)
• Have had at least one visit to a UPMC outpatient clinic location within the past year
• Can walk without an assistive device, such as a cane or walker
• Willing to undergo blood draws

WHAT PARTICIPANTS CAN EXPECT

Participation includes nine in-person visits and five phone calls over approximately 94 days. Participants will be randomly assigned (like a flip of a coin) to receive Urea either during the first part or the last part of study participation. Study visits include answering questions, undergoing a physical examination, giving blood and urine samples, and completing mental and physical tests. Participants will also be asked to restrict fluid intake during the study.