Study Summary
This trial is studying whether a supplement called urea could be used to treat low blood sodium levels. The goal is to learn if it's safe, if patients can tolerate it, if it raises blood sodium levels, and if it prevents brain fog or loss of balance.
Eligible Conditions
- Low Sodium
- Syndrome of Inappropriate Antidiuretic Hormone (SIADH)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
17 Primary · 7 Secondary · Reporting Duration: 13.5 months
13.5 months
Monthly Enrollment Rate
Number and Proportion of Participants Enrolled who Completed the Study
Number and Proportion of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
Number and Proportion of Patients Screened who Met Inclusion/Exclusion Criteria for the Study
Number of Patients Screened
Baseline to 42 days
Change in Percentage Angular Deviation of Visual Control System using Dynamic Representation of Upright Stance
Baseline to day 42
Change in Amplitude Scaling of Posture Control and Stability using Dynamic Representation of Upright Stance
Change in Movement Latency of Posture Control and Stability using Dynamic Representation of Upright Stance
Change in Overall Score of Sensorimotor Ability Battery
Change in Percentage Accuracy Action Boundary Selection
Change in Percentage Angular Deviation of Somatosensory Control System using Dynamic Representation of Upright Stance
Change in Percentage Angular Deviation of Vestibular Control System using Dynamic Representation of Upright Stance
Change in Percentage Weight Symmetry using Dynamic Representation of Upright Stance
Change in Plasma Sodium Concentration
Change in SF-12 (Health Survey) Mental Component Summary (MCS)
Change in SF-12 (Health Survey) Physical Component Summary (PCS)
Change in the Sample Entropy of the Center of Pressure Data from the Force Plate
Day 42
Adverse Events Related to Urea
Average Ratings for Medication Acceptability
Number and Proportion of Participants Enrolled in the Study with Adverse Events Related to the Use of Urea
Pharmaceutical Preparations
Number and Proportion of Participants who Took More than 80 Percent of Prescribed Urea Doses
Number of Prescribed Urea Doses Taken by Participants
Reasons for Non-Adherence to Urea Therapy
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
On Urea, Then Off Urea
1 of 2
Off Urea, Then On Urea
1 of 2
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Urea · No Placebo Group · Phase 2
On Urea, Then Off Urea
Drug
Experimental Group · 1 Intervention: Urea · Intervention Types: DrugOff Urea, Then On Urea
Drug
Experimental Group · 1 Intervention: Urea · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urea
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 13.5 months
Who is running the clinical trial?
Helbert Rondon Berrios, MD, MSLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,182 Previous Clinical Trials
4,088,867 Total Patients Enrolled
Helbert Rondon Berrios, MD. MSPrincipal InvestigatorUniversity of Pittsburgh
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Renneboog, Benoit, Wim Musch, Xavier Vandemergel, Mario U. Manto, and Guy Decaux. 2006. “Mild Chronic Hyponatremia Is Associated with Falls, Unsteadiness, and Attention Deficits”. The American Journal of Medicine. Elsevier BV. doi:10.1016/j.amjmed.2005.09.026.
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- Wallmann HW. Comparison of elderly nonfallers and fallers on performance measures of functional reach, sensory organization, and limits of stability. J Gerontol A Biol Sci Med Sci. 2001 Sep;56(9):M580-3. doi: 10.1093/gerona/56.9.m580.
- Schrier RW, Gross P, Gheorghiade M, Berl T, Verbalis JG, Czerwiec FS, Orlandi C; SALT Investigators. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med. 2006 Nov 16;355(20):2099-112. doi: 10.1056/NEJMoa065181. Epub 2006 Nov 14.
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- Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Nephrol Dial Transplant. 2014 Apr;29 Suppl 2:i1-i39. doi: 10.1093/ndt/gfu040. Epub 2014 Feb 25. Erratum In: Nephrol Dial Transplant. 2014 Jun;40(6):924.
- Rondon-Berrios H, Berl T. Mild Chronic Hyponatremia in the Ambulatory Setting: Significance and Management. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2268-78. doi: 10.2215/CJN.00170115. Epub 2015 Jun 24.
- Decaux G. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by long loop diuretics. Nephron. 1983;35(2):82-8. doi: 10.1159/000183052. No abstract available.
- Rozen-Zvi B, Yahav D, Gheorghiade M, Korzets A, Leibovici L, Gafter U. Vasopressin receptor antagonists for the treatment of hyponatremia: systematic review and meta-analysis. Am J Kidney Dis. 2010 Aug;56(2):325-37. doi: 10.1053/j.ajkd.2010.01.013. Epub 2010 Jun 9.
- Helbert Rondon Berrios, MD, MS 2022. "Urea for Chronic Hyponatremia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04588207.
Frequently Asked Questions
How many test subjects are helping researchers with this clinical trial?
"Yes, this is an ongoing study that was originally posted on March 29th, 2022 and updated September 13th, 2022. They are looking for 30 participants at a single site." - Anonymous Online Contributor
Unverified Answer
What are some key functions of Urea in the body?
"Urea is a common medication for the treatment of psoriasis. It can also help patients with dry eyes, neurodermatitis, and other skin conditions." - Anonymous Online Contributor
Unverified Answer
What are the investigators of this trial hoping to accomplish?
"The aim of this study, which will run from Baseline to day 42, is to assess the number and proportion of participants who complete the trial. Additionally, secondary outcomes such as change in SF-12 mental component summary (MCS) and physical component summary (PCS), as well as average ratings for medication acceptability will be evaluated." - Anonymous Online Contributor
Unverified Answer
Are there any unfilled vacancies for this experiment?
"Yes, this study is still looking for patients to enroll. The clinical trial was originally posted on 3/29/2022 and has had a recent update on 9/13/2022 according to the information available on clinicaltrials.gov" - Anonymous Online Contributor
Unverified Answer
Has the U.S. Food and Drug Administration given their okay to use urea?
"While there is some data affirming Urea's safety, it received a score of 2 because there are no studies yet proving its efficacy." - Anonymous Online Contributor
Unverified Answer