Urea for Chronic Hyponatremia: A Pilot Study

Who is this study for? Patients with Hyponatremia, Inappropriate ADH Syndrome
What treatments are being studied? Urea
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is examining how a dietary supplement called urea can be used to treat low blood sodium level. Low blood sodium level is a common problem and some studies show that many patients with low blood sodium level suffer from brain fog and/or loss of balance. Unfortunately, it is unknown at this point what the best treatment is for low blood sodium level. With this pilot research study, the investigators are hoping to learn more about whether urea is safe to take, whether patients can tolerate taking urea for several weeks, whether urea increases blood sodium level, and whether urea can help prevent the brain fog and/or loss of balance that some patients with low blood sodium level suffer from. The information obtained with this study is intended to be used to design a larger study in the future to get a definite answer whether urea is beneficial for patients with low blood sodium level.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age ≥18 years

• Attended ≥1 visit at a University of Pittsburgh Medical Center (UPMC) outpatient clinic within the prior 12 months

• Chronic hyponatremia with a history of ≥ 2 sequential plasma sodium concentration (PNa) between 125 mmol/L and 132 mmol/L performed ≥ 14 days apart within the last 12 months with most recent PNa ≤ 132 mmol/L prior to screening

• Patients are ambulatory without the need for any assist device (e.g., cane, walker)

• Mini-mental state examination (MMSE) score ≥ 25

• Diagnosis of SIADH established by the Bartter and Schwartz criteria as follows:

• Hyponatremia with a PNa between 125 mmol/L and 132 mmol/L

• Plasma osmolality < 275 mOsm/kg

• Clinical euvolemia

• Urine osmolality > 100 mosm/kg

• Urine Na ≥ 20 mmol/L

• Intact adrenal function (i.e., morning plasma cortisol value ≥15 μg/dL, or negative corticotropin stimulation test)

• Normal thyroid stimulating hormone (TSH) level (i.e., TSH between 0.3 to 5 μIU/mL)

• eGFR >= 45 ml/min/1.73 m2)

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Contact Information
Primary
Rachel Cohen, BA, RN
rkc16@pitt.edu
412-647-1376
Time Frame
Start Date: March 29, 2022
Estimated Completion Date: May 31, 2023
Participants
Target number of participants: 30
Treatments
Experimental: On Urea, Then Off Urea
Participants assigned to this group will receive oral urea for 42 days (period 1), followed by a 10-day washout period, and then will be off urea for 42 days (period 2).
Experimental: Off Urea, Then On Urea
Participants assigned to this group will be off urea during for 42 days (period 1), followed by a 10-day washout period, and then on urea for 42 days (period 2)
Authors
Helbert Rondon Berrios
Sponsors
Leads: Helbert Rondon Berrios, MD, MS
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov

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