MitoQ
Dietary SupplementOral; 20mg once a day for 14 days
NCT Number: NCT04109820
MitoQ is commercially available as a dietary supplement and it has been tested as a potential drug in other diseases, but it has never been tested in patients with sickle cell disease.
The goal of this research is to study if MitoQ, a molecule that works as an antioxidant by removing potentially damaging agents in a living organism, improves platelet function in patients with sickle cell disease (SCD).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Antioxidant therapies targeted to specific enzymes or compartments may be beneficial in sickle cell anemia (SCA). MitoQ, the most extensively studied mitochondrial-targeted antioxidant, has been shown to be protective against ischemia/reperfusion injury in the heart, endothelial damage due to hypertension and ROS in animal models. MitoQ is commercially available as a dietary supplement to reduce overall oxidative stress and anti-ageing. However, MitoQ has not been tested either as a platelet antagonist or as an endothelial protectant in SCA patients. Investigators propose to conduct a small clinical trial of MitoQ in subjects with SCA to test the hypothesis that MitoQ scavenges platelet mtROS to prevent platelet activation and attenuate vascular dysfunction in SCA.
Investigators will test whether MitoQ decreases basal platelet activation in SCD patients and attenuates vascular dysfunction in subjects with SCA. Investigators will administer MitoQ orally to patients and healthy controls for 14 days. Investigators will obtain platelet count, hemolytic markers, platelet mtROS levels and activation markers, clinic BP measurements before and after MitoQ.
Adult male and female SCA subjects in steady state (n=10) and 5 healthy African-American volunteers will be recruited after obtaining informed consent.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects
Control
Exclusion criteria
Oral; 20mg once a day for 14 days
Time frame: Baseline to 14 days
Change in the percentage of platelet activation markers in blood will be measured (p-selectin, activated GpIIb/IIIa expression, platelet mtROS [mitochondrial reactive oxygen species], platelet bioenergetics, mitochondrial Complex V activity)
Time frame: Baseline to 14 days
Changes in both systolic and diastolic blood pressure will be measured during the study period
Time frame: Baseline to 14 days
Changes in plasma free hemoglobin level (mg/dL) will be measured in blood.
Time frame: Baseline to 14 days
Changes in plasma adenosine diphosphate level (micromole/liter) will be measured in blood.
Time frame: Baseline to 14 days
Changes in serum lactate dehydrogenase level (units/L) will be measured in blood.
Time frame: Baseline to 14 days
Overall incidence of treatment emergent severe adverse events (SAE)
Contact information is provided by the study sponsor or research team.
Jude Jonassaint, RN
CONTACT
Mikhil N Bamne, PhD
CONTACT
University of Pittsburgh
Other
Effect of MitoQ on Platelet Function and Reactive Oxygen Species (ROS) Generation in Patients With Sickle Cell Anemia
Acronym: MitoQ
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07187973
Anemia, Anemia, Hemolytic
Birmingham, Alabama, United States
View Trial DetailsNCT00542230
Anemia, Anemia, Hemolytic
Bethesda, Maryland, United States
View Trial DetailsNCT03937817
Alpha and Beta Thalassemia, Anemia
Bethesda, Maryland, United States
View Trial DetailsNCT02675959
Anemia, Anemia, Hemolytic
Los Angeles, California, United States
View Trial Details