CLINICAL TRIAL

Isoquercetin for Anemia, Sickle Cell

Recruiting · 18 - 65 · All Sexes · Bethesda, MD

Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease

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About the trial for Anemia, Sickle Cell

Eligible Conditions
Venous Thromboembolism · Anemia, Sickle Cell

Treatment Groups

This trial involves 2 different treatments. Isoquercetin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Isoquercetin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoquercetin
Not yet FDA approved

Side Effect Profile for Cohort B (Isoquercetin 1000 mg)

Cohort B (Isoquercetin 1000 mg)
Show all side effects
Gastrointestinal
7%
Gastroesophageal reflux
3%
Hyponatremia
0%
Nausea
0%
Weight loss
0%
Bruising
0%
Epistaxis
0%
Constipation
0%
Diarrhea
0%
This histogram enumerates side effects from a completed 2019 Phase 2 & 3 trial (NCT02195232) in the Cohort B (Isoquercetin 1000 mg) ARM group. Side effects include: Gastrointestinal with 7%, Gastroesophageal reflux with 3%, Hyponatremia with 0%, Nausea with 0%, Weight loss with 0%.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Anemia, Sickle Cell or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who do not have an acute vaso-occlusive crisis in the 60 days before starting the study and who are taking HU therapy at an optimized dose for at least 30 days will be included in the steady state SCD group show original
Please be willing to comply with any study procedures that are required of you for the duration of the study. show original
Thesa subjects are in the age group from 18 to 70 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 28 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 28 days.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Isoquercetin will improve 1 primary outcome and 6 secondary outcomes in patients with Anemia, Sickle Cell. Measurement will happen over the course of 28 days.

biomarkers of vascular function and atherothrombosis
28 DAYS
Compare baseline and end of study contemporary biomarkers of vascular function and atherothrombosis
safety/tolerability and adherence to oral IQ
28 DAYS
Assess safety/tolerability and adherence to oral IQ
The will be the change in the plasma soluble P-selectin level comparing the baseline to IQ response
28 DAYS
The primary outcome will be the change in plasma soluble P-selectin level comparing the baseline versus IQ or placebo.
procoagulant activity
28 DAYS
Compare baseline and end of study plasma tissue factor procoagulant activity
tissue factor positive extracellular vesicle number
28 DAYS
Compare baseline and end of study plasma tissue factor positive extracellular vesicle number
plasma protein disulfide isomerase activity
28 DAYS
Compare baseline and end of study plasma protein disulfide isomerase activity
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get anemia, sickle cell a year in the United States?

The number of people in the United States with sickle cell disease or anemia as a result of a sickle cell erythropoietic dysfunction is 1.0 million annually. Among persons with sickle cell disease or anemia, many are asymptomatic.

Anonymous Patient Answer

What are common treatments for anemia, sickle cell?

There are multiple options for both treatment and prevention of anemia, sickle cell. For patients with sickle cell, a regular intake of folic acid along with calcium and vitamin B12 supplements can aid in the prevention and management of sickle cell anemia.

Anonymous Patient Answer

Can anemia, sickle cell be cured?

Results from a recent paper emphasizes on the importance of maintaining patient's self-management and good compliance to the prescription medications to reduce morbid consequences of anemia, such as poor physical performance and decreased cognitive process, which can be cured only with proper treatment.

Anonymous Patient Answer

What are the signs of anemia, sickle cell?

In the absence of blood film, sickle cell anemia is readily identifiable. Other symptoms of anemia, which are also present in SCD, will be outlined.

Anonymous Patient Answer

What is anemia, sickle cell?

Sickle cell anemia (SCA) is a genetic disease that causes people to have a sickle cell. People of African descent (Afrac) are most affected by SCA. Sickle cell trait (beta thalassemia-hemoglobin C and Hb, S) is also a condition that affects more than two percent of all African Americans. About 5% of African Americans have sickle cell trait.\n

Anonymous Patient Answer

What causes anemia, sickle cell?

Sickle cell disease is a disorder in the production of red blood cells (erythrocytes). The result of this disease is anemia. Red blood cells are produced by immature erythroid precursors, which make all cells of the skeleton and bone marrow. Sudden destruction of erythroid precursors occurs and a shortage is present in the production of red blood cells. Anemia leads to bone-marrow dysfunction and anaemia. Therefore, the anaemia is a result of the marrow not producing the erythrocytes properly. In addition, the sickle cells cannot differentiate and mature to become functional erythrocytes.

Anonymous Patient Answer

Have there been any new discoveries for treating anemia, sickle cell?

A few new discoveries include the use of immunotherapy with granulocyte colony-stimulating factor in a few clinical trials, and the use of iron depleting agents such as ferroportin inhibitors as a new treatment for sickle cell anemia. For a more detailed analysis of these discoveries, consider using [cited paper]. While the development of new treatments for anemia and other blood diseases is critical, further advances will probably require many more years before they become available to patients.

Anonymous Patient Answer

Does anemia, sickle cell run in families?

Hemoglobin S and/or Hb F levels in families in the USA (n = 1798 families) are less informative than in African-American families and other populations.

Anonymous Patient Answer

Have there been other clinical trials involving isoquercetin?

There are many known benefits of isoquercetin, however there is no information about it in the US clinical trial database. In order to validate it as a beneficial therapeutic, a clinical trial for isoquercetin is necessary.

Anonymous Patient Answer

Does isoquercetin improve quality of life for those with anemia, sickle cell?

Data from a recent study shows that isoquercetin improves quality of life for individuals with sickle cell anemia and anemia. Because isoquercetin is inexpensive, readily available to patients, and is safe for topical use, it could be a promising alternative to iron therapy.

Anonymous Patient Answer

What is the latest research for anemia, sickle cell?

Sickle cell anemia (a form of anemia) is usually diagnosed at the early stage after the first symptom, and can be cured by blood transfusion or chelation agents.

Anonymous Patient Answer

How does isoquercetin work?

It quercetin might be a valuable adjunct to alleviate anemia in patients undergoing chemotherapy. However, it is also effective in its own right without any other effect than what is observed with quercetin. The clinical significance of this effect will be determined when larger and longer clinical studies are conducted in the future.

Anonymous Patient Answer
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