RECRUITING

Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

Talk to us

Conditions

Chronic Kidney Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

Quick Facts

Study Start:2019-05-01
Study Completion:2024-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03826147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Ability to give informed consent
  3. * Albumin \> 3.0 g/dL
  4. * Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
  5. * Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
  6. * Mini-mental state examination score \>21 (rationale: to screen for subjects with major cognitive impairment)
  7. * 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)
  8. * Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
  9. * Body mass index (BMI) \<40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)
  1. * Life expectancy \<1 year
  2. * Uncontrolled hypertension, defined as blood pressure \> 160/100 mmHg in the past 3 months
  3. * History of severe liver disease
  4. * History of severe congestive heart failure (i.e., ejection fraction \< 35%)
  5. * History of hospitalizations within the last 3 months
  6. * Active infection or antibiotic therapy
  7. * Warfarin use
  8. * Vasculitis requiring immunosuppressive therapy within the last year
  9. * High dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites
  10. * Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin \>2%
  11. * 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
  12. * Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study

Contacts and Locations

Study Contact

Hannah Lally
CONTACT
303-735-6410
beetrootstudy@colorado.edu

Principal Investigator

Matthew J Rossman, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder

Study Locations (Sites)

Integrative Physiology of Aging Laboratory
Boulder, Colorado, 80309
United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

  • Matthew J Rossman, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01
Study Completion Date2024-07

Study Record Updates

Study Start Date2019-05-01
Study Completion Date2024-07

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease