Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Status:
Recruiting
Trial end date:
2022-10-28
Target enrollment:
Participant gender:
Summary
Background:
Sickle cell disease (SCD) is an inherited hemoglobin disorder. People with SCD have an
increased chance for getting blood clots. Researchers want to see if a dietary supplement
called Isoquercetin can decrease levels of inflammation and blood clotting in people with
SCD.
Objective:
To see how Isoquercetin works in people with SCD.
Eligibility:
Adults age 18-70 years old who have SCD and are in a steady-state (have not experienced a
pain crisis in the last 60 days and, if taking hydroxyurea, have not had a dose change in the
past 90 days).
Design:
Participants will be screened with a physical exam, medical history, medicine review, and
blood tests.
Participants may have a peripheral arterial tonometry (Endo-Pat) test to check the function
of their blood vessels. For this, a thimble-shaped cup is placed on their finger and a blood
pressure cuff is placed on their arm.
Participants will be put in 1 of 2 treatment groups. They will take 4 capsules of
Isoquercetin or placebo all at once, by mouth, every day for 4 weeks. They will get a pill
dispenser and keep a medicine diary.
Participants will take folic acid once a day.
Participants will have an end-of-study visit. They will discuss any side effects and repeat
some of the screening tests. They may have an Endo-Pat test.
About a month after the last study visit, participants will be contacted by phone to see if
they have any side effects. Those who do may have a follow-up visit. At this visit, they may
have blood tests.
Participation will last from 8 to 12 weeks.