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Antioxidant

MitoQ for Sickle Cell Disease (MitoQ Trial)

N/A
Recruiting
Led By Ramasubramanian Kalpatthi, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Subjects
Must not have
Known hypertension
Hemodialysis and active obstructive sleep apnea requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if MitoQ is safe and effective in improving platelet function in patients with SCD.

Who is the study for?
This trial is for African American adults over 18 with sickle cell anemia. Healthy African American adults can also participate as controls. People cannot join if they are pregnant, have known high blood pressure, use anti-platelet medication, had a transfusion within the last month, require hemodialysis or treatment for obstructive sleep apnea.
What is being tested?
The study is testing MitoQ, an antioxidant supplement not yet studied in sickle cell disease patients. It aims to see if MitoQ can improve how platelets function and reduce harmful oxygen-related molecules in those with sickle cell disease.
What are the potential side effects?
Since this is a new test of MitoQ in sickle cell disease patients, specific side effects aren't fully known but may include typical reactions to supplements such as digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I'm sorry, it seems that you have not completed the sentence. Could you please provide me with the complete criterion?
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I have sickle cell anemia.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with high blood pressure.
Select...
I am on hemodialysis and need treatment for obstructive sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of MitoQ on platelet activation markers in subjects with SCA
Secondary study objectives
Hemolysis (disorder)
Effect of MitoQ on vascular dysfunction in subjects with SCA
Treatment related severe adverse events (SAE)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sickle cell patientsExperimental Treatment1 Intervention
Sickle Cell subjects administered oral MitoQ (20mg once a day for 14 days)
Group II: Non Sickle cell Control subjectsActive Control1 Intervention
Normal control subjects administered oral MitoQ (20mg once a day for 14 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitoQ
2006
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,961 Total Patients Enrolled
Ramasubramanian Kalpatthi, MDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh

Media Library

Sickle Cell Disease Clinical Trial 2023: MitoQ Highlights & Side Effects. Trial Name: NCT04109820 — N/A
~3 spots leftby Dec 2025
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