Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514510
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2020-08-14
Brief Title:
Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study to Evaluate the Effects of Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 may have an optional near infrared spectroscopy NIRS test to measure how treatment affects blood flow In this test probes will be placed on the skin to measure tissue oxygen level and blood flow A blood pressure cuff placed on the arm will be filled with air briefly to restrict the blood flow in the arm for up to 5 minutes and then released Participants may also be asked to breathe at a certain rate or hold their breath for as long as they can during measurements
Participants will take folic acid once a day
Participants will have an end-of-study drug visit They will discuss any side effects and repeat some of the screening tests They may have an additional optional NIRS test
About a month after the end of study drug 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 additional blood tests performed
Participation will last from 8 to 12 weeks
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 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 may have an optional near infrared spectroscopy NIRS test to measure how treatment affects blood flow In this test probes will be placed on the skin to measure tissue oxygen level and blood flow A blood pressure cuff placed on the arm will be filled with air briefly to restrict the blood flow in the arm for up to 5 minutes and then released Participants may also be asked to breathe at a certain rate or hold their breath for as long as they can during measurements
Participants will take folic acid once a day
Participants will have an end-of-study drug visit They will discuss any side effects and repeat some of the screening tests They may have an additional optional NIRS test
About a month after the end of study drug 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 additional blood tests performed
Participation will last from 8 to 12 weeks
Detailed Description:
Sickle Cell Disease SCD is an inherited monogenic hemoglobin disorder caused by a mutation in the gene encoding the beta globin subunit of adult hemoglobin HbA resulting in a substitution of valine for glutamic acid at position 6 and thus producing hemoglobin S HbS When deoxygenated HbS polymerizes rendering the red cell rigid viscous and abnormally adherent to the capillary endothelium This impedes blood flow in the microcirculation causing ischemia and microinfarcts that lead to painful crises cerebrovascular stroke renal impairment venous blood clots retinopathy and other end-organ damage The current scientific literature recognizes the contribution of an acquired hypercoagulable state in SCD to vascular pathobiology chronic organ dysfunction and mortality
Like cancer SCD is associated with a hypercoagulable state and patients have a high risk of new onset and recurrent venous thromboembolism VTE Elevated blood levels of the procoagulant protein tissue factor and its activator protein disulfide isomerase PDI in patients with SCD suggest a causal role for these proteins in the development of venous blood clots In cancer patients inhibiting plasma PDI activity with isoquercetin IQ led to a significant reduction in VTE biomarkers soluble P-selectin and D-dimer and venous thrombosis over the short term These findings provide support to test the hypothesis that isoquercetin treatment in sickle cell disease would diminish thrombo-inflammatory biomarkers and attenuate the hypercoagulable state
Like cancer SCD is associated with a hypercoagulable state and patients have a high risk of new onset and recurrent venous thromboembolism VTE Elevated blood levels of the procoagulant protein tissue factor and its activator protein disulfide isomerase PDI in patients with SCD suggest a causal role for these proteins in the development of venous blood clots In cancer patients inhibiting plasma PDI activity with isoquercetin IQ led to a significant reduction in VTE biomarkers soluble P-selectin and D-dimer and venous thrombosis over the short term These findings provide support to test the hypothesis that isoquercetin treatment in sickle cell disease would diminish thrombo-inflammatory biomarkers and attenuate the hypercoagulable state
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-H-0137 | None | None | None |