Tier 2 — strong

Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial

Jing Chen, L Lee Hamm, Joshua D Bundy, Damodar R Kumbala, Shirisha Bodana, Sehgal Chandra, Chung-Shiuan Chen, Charlton C Starcke, Yajun Guo, Caroline M Schaefer, Eva Lustigova, Erin Mahone, Aarti M Vadalia, Terra Livingston, Katherine Obst, Jesus Hernandez, Syed Rizwan Bokhari, Myra Kleinpeter, Arnold B Alper, Ivo Lukitsch, Hua He, David C Nieman, Jiang He
Clinical journal of the American Society of Nephrology : CJASN 2020 15(11):1566-1575

Bibliography

PubMed
PMID 33023894
PubMed Central
PMC7646238
DOI
10.2215/CJN.02020220
Funding
Reported funding/support: National Institute of General Medical Sciences of the National Institutes of HealthU54 GM104940National Institute of Health (NIH); National Institute of General Medical Sciences (NIGMS)P20 GM109036NIH; NIGMSP30-GM103337
Competing interests
A competing-interest declaration was not available in the indexed record or the disclosure metadata used for this entry.

Study snapshot

DesignRandomized double-blind placebo-controlled phase 2 pilot
ModelHuman intervention research
Sample70 adults with predialysis chronic kidney disease
InterventionSodium nitrite 40 mg twice daily plus isoquercetin 225 mg/day versus placebo
Duration12 weeks
EndpointsInflammatory measures

What the study showed, in plain terms

Published in 2020, this source examined cardiovascular and metabolic health. Design: Randomized double-blind placebo-controlled phase 2 pilot. Sample/model: 70 adults with predialysis chronic kidney disease. The exposure or intervention was Sodium nitrite 40 mg twice daily plus isoquercetin 225 mg/day versus placebo. Follow-up or treatment period: 12 weeks.

The primary flow-mediated dilation endpoint and other vascular, inflammatory and kidney outcomes did not improve significantly.

Combination treatment and short follow-up. No kidney-protection or cardiovascular-event benefit was established.

Continue with Quercetin Data Center

For topic-level interpretation, read Quercetin and Blood Pressure: How Large Is the Effect?. This is a related guide; the citation panel separately identifies articles that directly cite this paper.

Key findings

  • The primary flow-mediated dilation endpoint and other vascular, inflammatory and kidney outcomes did not improve significantly.
  • The recorded outcome domains were Inflammatory measures.
  • The result applies to the tested exposure: Sodium nitrite 40 mg twice daily plus isoquercetin 225 mg/day versus placebo; 12 weeks.

What this study can and cannot tell us

  • Combination treatment and short follow-up. No kidney-protection or cardiovascular-event benefit was established.
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Source check: accessible full text and indexed metadata. Missing method details, funding information or participant denominators are not inferred.

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Editorial review

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology