Status:
UNKNOWN
Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease
Lead Sponsor:
University of Colorado, Boulder
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Nitric oxide (NO) is an essential molecule in the body that is decreased in patients with chronic kidney disease (CKD), leading to reductions in vascular, movement ("motor") and cognitive functions. T...
Eligibility Criteria
Inclusion
- CKD stage II-IV (eGFR using the Modification of Diet in Renal Disease (MDRD) prediction equation 20-90 mL/min/1.73m2; stable renal function in the past 3 months)
- Ability to give informed consent
- Albumin \> 3.0 g/dL
- Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
- Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- Mini-mental state examination score \>21 (rationale: to screen for subjects with major cognitive impairment)
- Blood pressure (BP) \>100/60 mmHg for past 3 months (rationale: blood pressure below 100/60 mmHg may elevate the normally small risk of hypotension with nitrate supplementation)
- Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
- Body mass index (BMI) \<40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)
Exclusion
- Life expectancy \<1 year
- Uncontrolled hypertension, defined as blood pressure \> 160/100 mmHg in the past 3 months
- History of severe liver disease
- History of severe congestive heart failure (i.e., ejection fraction \< 35%)
- History of hospitalizations within the last 3 months
- Active infection or antibiotic therapy
- Warfarin use
- Vasculitis requiring immunosuppressive therapy within the last year
- High dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites
- Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin \>2%
- Unwilling to abstain from use of mouthwash or other oral hygiene practices (e.g., tongue scraping) outside of teeth brushing that disrupt the oral microbiome and would interfere with nitrate conversion to nitrite
- Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03826147
Start Date
May 1 2019
End Date
July 1 2024
Last Update
May 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Integrative Physiology of Aging Laboratory
Boulder, Colorado, United States, 80309