NCT03826147Active, not recruitingPhase 4
Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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. This study will determine if daily oral supplementation (3 months) with a supplement that increases NO in the body, i.e., nitrate-rich beetroot juice, improves vascular, motor and cognitive function in patients with CKD; this study will also provide insight into the biological reasons (mechanisms) by which supplementation with nitrate-rich beetroot juice improves vascular function in these patients. Overall, this research will provide scientific evidence supporting the use of nitrate-rich beetroot juice for preserving physiological function and preventing co-morbid clinical conditions and disability in CKD.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 28 Jan 2019
- Start date
- 1 May 2019
- Primary completion date
- Jul 2026
- Lead sponsor
- University of Colorado, Boulder
- Diseases
- Chronic kidney disease
- NCT number
- NCT03826147
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 92
- From 1 May 2019 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vasculitis requiring immunosuppressive therapy within the last year
- Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study
Other illness
- Uncontrolled hypertension, defined as blood pressure \> 160/100 mmHg in the past 3 months
- History of severe liver disease
- History of hospitalizations within the last 3 months
- Active infection or antibiotic therapy
- High dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites
Lab values
- History of severe congestive heart failure (i.e., ejection fraction \< 35%)
- Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin \>2%
Other
- Life expectancy \<1 year
- Warfarin use
- 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
Who the study is looking for
- 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)
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Integrative Physiology of Aging Laboratory Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
Related publications
- Sex Differences in Dementia and Mild Cognitive Impairment in Nondialysis CKD.Clin J Am Soc Nephrol · 2026 · PMID 41264372
This page is information, not medical advice. Discuss any trial with your doctor.