Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 2/3/2019 |
| Start Date: | February 2019 |
| End Date: | July 2023 |
| Contact: | Erzsebet Nagy |
| Email: | Erzsebet.nagy@colorado.edu |
| Phone: | 303-492-4568 |
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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