Tier 2 — strong

Phase 1 study of quercetin, a natural antioxidant for children and young adults with Fanconi anemia

Parinda A Mehta, Adam Nelson, Sara Loveless, Adam Lane, Tsuyoshi Fukuda, Ashley Teusink-Cross, Deborah Elder, Denise Lagory, Erica Miller, Jose A Cancelas, Jonathan Howell, Junfang Zhao, Kana Mizuno, Kasiani C Myers, Kelly Lake, Kelly McIntosh, Kenneth D R Setchell, Nathan Luebbering, Stephanie Edwards, Tafadzwa Chihanga, Susanne I Wells, Stella M Davies
Blood advances 2025 9(8):1927-1939

Bibliography

PubMed
PMID 39820512
PubMed Central
PMC12008688
DOI
10.1182/bloodadvances.2024015053
Funding
Indexed grant support: R01 DK124115 — NIDDK NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
Reported disclosure: Conflict-of-interest disclosure: P.A.M. is a board member at Orthogon Therapeutics. D.E. receives research support from Dexcom and Sanofi. J.H. is a consultant for EMD Serono. K.C.M. receives research funding from Elixirgen Therapeutics and Incyte. K.D.R.S. holds equity in Asklepion Pharmaceuticals and Aliveris s.r.l.; and is a consultant for Mirum Pharmaceuticals. The remaining authors declare no competing financial interests.

Study snapshot

DesignOpen-label phase 1 dose-finding and expansion study
ModelHuman intervention research
Sample12 dose-finding participants; 18 in expansion; median age 7 in dose-finding
InterventionBodyweight-adjusted twice-daily quercetin; maximum adult-equivalent dose 4,000 mg/day
Duration4 months in dose-finding; 6 months in expansion
EndpointsOxidative-stress measures; Platelet or coagulation measurements

What the study showed, in plain terms

Published in 2025, this source examined safety, interactions and special populations. Design: Open-label phase 1 dose-finding and expansion study. Sample/model: 12 dose-finding participants; 18 in expansion; median age 7 in dose-finding. The exposure or intervention was Bodyweight-adjusted twice-daily quercetin; maximum adult-equivalent dose 4,000 mg/day. Follow-up or treatment period: 4 months in dose-finding; 6 months in expansion.

Treatment was tolerated and some oxidative-stress measures improved. Platelets were broadly stable, while neutrophils and hemoglobin declined over follow-up.

Rare-disease monitored protocol. Blood-count fluctuations and the uncontrolled design limit efficacy conclusions; this is not general pediatric dosing guidance.

Continue with Quercetin Data Center

For topic-level interpretation, read Quercetin Side Effects and Safety: A Practical Guide. This is a related guide; the citation panel separately identifies articles that directly cite this paper.

Key findings

  • Treatment was tolerated and some oxidative-stress measures improved.
  • Platelets were broadly stable, while neutrophils and hemoglobin declined over follow-up.
  • The recorded outcome domains were Oxidative-stress measures; Platelet or coagulation measurements.
  • The result applies to the tested exposure: Bodyweight-adjusted twice-daily quercetin; maximum adult-equivalent dose 4,000 mg/day; 4 months in dose-finding; 6 months in expansion.

What this study can and cannot tell us

  • Rare-disease monitored protocol. Blood-count fluctuations and the uncontrolled design limit efficacy conclusions; this is not general pediatric dosing guidance.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Source check: accessible full text and indexed metadata. Missing method details, funding information or participant denominators are not inferred.

Related papers in the corpus

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Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease
Meilan K Han et al. · BMJ open respiratory research · 2020
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Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin
Antonella Riva et al. · Minerva cardioangiologica · 2019
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The effect of quercetin on the pharmacokinetics of chlorzoxazone, a CYP2E1 substrate, in healthy subjects
Satish Kumar Bedada et al. · European journal of clinical pharmacology · 2018

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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