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Urea for Low Sodium

Phase 2
Waitlist Available
Led By Helbert Rondon Berrios, MD. MS
Research Sponsored by Helbert Rondon Berrios, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13.5 months
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events Related to Urea
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
+14 more
Secondary outcome measures
Average Ratings for Medication Acceptability
Change in SF-12 (Health Survey) Mental Component Summary (MCS)
Change in SF-12 (Health Survey) Physical Component Summary (PCS)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: On Urea, Then Off UreaExperimental Treatment1 Intervention
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).
Group II: Off Urea, Then On UreaExperimental Treatment1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urea
2007
Completed Phase 4
~100

Find a Location

Who is running the clinical trial?

Helbert Rondon Berrios, MD, MSLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,064 Total Patients Enrolled
Helbert Rondon Berrios, MD. MSPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~1 spots leftby Apr 2025