Quercetin Dyskeratosis Congenita (DC)/Telomere Biology Disorders (TBD)

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07628972
Phase
PHASE1
Status
Recruiting
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Conditions

  • Dyskeratosis Congenita
  • Telomere Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quercetin — DRUG
    Quercetin (3, 30, 40, 5, 7-pentahydroxyflavone) is a naturally occurring antioxidant that belongs to a group of polyphenolic compounds known as flavonoids. Quercetin is routinely available as an over-the-counter product due to it being a nutritional supplement. However, for the purpose of the study, it will be purchased in the powder form from PCCA (supplied as 96% quercetin dihydrate) and stored and distributed by the investigational pharmacy at CCHMC using standard operational procedures. Quercetin is administered as an oral medication, supplied in powder form. Quercetin will be stored at room temperature. The product will be dispensed for home administration. Each packet will be labeled in accordance with applicable regulatory requirements. Patients or parents will be instructed to mix it with a small amount of yogurt or other preferred food for ingestion.

Study Details

The purpose of this study is to see if a vitamin-like substance called quercetin is safe for people who have a rare condition called Dyskeratosis congenita (DC) or telomere biology disorders (TBD).

Key Dates

Start date
May 29, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Quercetin
    Quercetin dose (based on patient weight and as a percentage of adult dose - as noted in Table 2) will be given orally on a twice a day schedule starting with weight adjusted maximum total daily dose of 4000 mg/day (and administered in divided doses bid). For patients who weigh 70 kg or more, the starting dose will be automatically assigned at the maximum dose of 4000 mg/day.

Primary Outcome Measure

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229

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