Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.

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Detailed Description

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The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease. Investigators will recruit 70 albuminuric CKD patients and randomly assign participants to combination therapy with sodium nitrite and isoquercetin or placebo for three months.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment

Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day.

Group Type EXPERIMENTAL

Immediate release sodium nitrite

Intervention Type DRUG

Immediate release sodium nitrite 40 mg by mouth twice per day

Isoquercetin

Intervention Type DIETARY_SUPPLEMENT

Isoquercetin 225 mg by mouth once per day

Placebos

identical placebos.

Group Type PLACEBO_COMPARATOR

placebos

Intervention Type OTHER

placebos

Interventions

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Immediate release sodium nitrite

Immediate release sodium nitrite 40 mg by mouth twice per day

Intervention Type DRUG

Isoquercetin

Isoquercetin 225 mg by mouth once per day

Intervention Type DIETARY_SUPPLEMENT

placebos

Intervention Type OTHER

Other Intervention Names

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TV1001 3-O-glucoside

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 21-74 years old with any race/ethnicity background
* CKD as defined by an eGFR \<60 ml/min/1.73 m2 or urinary albumin to creatinine ratio ≥ 30 mg/g or protein to creatinine ratio ≥150 mg/g.
* Systolic BP≥120 and \<180 mmHg and/or diastolic BP≥70 and \<110 mmHg

Exclusion Criteria

* Allergic to organic nitrite, isoquercetin, niacin, or vitamin C
* Institutionalized (e.g., prisoner, nursing home or skilled nursing facility resident)
* Unable or unwilling to give consent
* Known HIV infection and/or AIDS
* Pregnant or lactating women
* Currently on dialysis
* Previous or current organ or bone marrow transplant
* Receiving immunosuppressive treatment or other immunotherapy
* Receiving chemotherapy or alkylating agents for systemic cancer
* Recent acute myocardial infarction, cerebrovascular accidence or transient ischemic attack, or hospitalization in 3 months
* Acute kidney injury within the previous 3 months
* Currently taking a phosphodiesterase-5 enzyme inhibitor, such as Viagra
* History of chronic headaches
* Chronically receiving fluoroguinolones, cyclosporin (neural, sandimmune), nitrate drug, NSAIDS ( except aspirin ≤ 81 mg daily), allopurinol or uloric, meperidine and related central nervous system (CNS) depressants, oral glucocorticoids, and not willing or able to stop during study period.
* Active infection (i.e. systemic or osteomyelitis)
* Class III or IV heart failure
* History of hemolytic anemia including sickle cell disease
* Hemoglobin \<10
* History of chronic obstructive pulmonary disease (COPD)
* Have a positive screen for glucose-6-phosphate dehydrogenase (G6PD) deficiency at screening
* Involvement in other clinical trials
* Current alcohol or other substance abuse
* Current smokers
* Unwillingness to stop flavonoid supplementation
* Unwillingness to stop nitrate and/or nitrite supplementation

Minimum Eligible Age

21 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No