80 Participants NeededMy employer runs this trial

MitoQ for Pre-eclampsia

(MAVEN Trial)

JM
Overseen ByJennifer McIntosh, D.O., M.S.
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Medical College of Wisconsin

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MitoQ, a special type of antioxidant, can improve placental health and prolong pregnancy in women with preeclampsia, a serious pregnancy complication affecting blood flow. The researchers aim to determine if MitoQ can restore blood vessel function and improve outcomes for both mothers and babies. Pregnant participants diagnosed with preeclampsia (with or without severe features) who plan for continued management rather than immediate delivery might be suitable for this trial.

As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to better treatments for preeclampsia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mitoquinol Mesylate, or MitoQ, has been tested for safety in humans. This antioxidant is already in trials for other health issues. Studies suggest that MitoQ can help prevent preeclampsia if administered later in pregnancy. However, using it too early might increase the risk of preeclampsia, so timing is crucial.

In other studies, most participants tolerated MitoQ well, experiencing no serious side effects. However, like any treatment, some risks exist. This study focuses on using MitoQ later in pregnancy, which has shown positive results in previous research. Overall, evidence suggests that MitoQ is safe when used at the appropriate time during pregnancy.12345

Why are researchers excited about this trial?

Unlike the standard treatments for pre-eclampsia, which often focus on managing symptoms with blood pressure medications like labetalol or nifedipine, Mitoquinol Mesylate offers a new approach by directly targeting oxidative stress. This treatment is unique because it uses MitoQ, a powerful antioxidant designed to penetrate mitochondria, potentially reducing oxidative damage at the cellular level. Researchers are excited about MitoQ because it may address the root cause of some complications associated with pre-eclampsia, potentially improving outcomes for both mothers and their babies.

What evidence suggests that Mitoquinol Mesylate might be an effective treatment for preeclampsia?

Research has shown that Mitoquinol Mesylate, or MitoQ, may help treat preeclampsia. In this trial, some participants with preeclampsia will receive MitoQ, while others will receive a placebo. Studies have found that this antioxidant can improve blood vessel function and support healthier placentas. For instance, MitoQ proved more effective than other treatments at reducing harmful hydrogen peroxide levels in cells. Additionally, earlier studies showed that MitoQ could lower high blood pressure in pregnant women when used later in pregnancy. These findings suggest that MitoQ may help safely extend pregnancy and improve health outcomes for mothers and babies.12467

Who Is on the Research Team?

JJ

Jennifer J McIntosh, D.O.,

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-50 with preeclampsia (with or without severe features), between 23 and 34 weeks of a single-baby pregnancy, who do not need immediate delivery and can follow instructions. People with very high blood pressure, serious heart or nerve problems, recent head injury, blood clots, or severe long COVID cannot join.

Inclusion Criteria

I am 18-50, pregnant with one baby, have severe preeclampsia, and am 23-32 weeks along.
I am 18-50, pregnant with one baby, have mild preeclampsia, and can manage care at home.

Exclusion Criteria

Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
I have peripheral vascular disease.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MitoQ or placebo daily from enrollment until delivery to improve vascular function in preeclampsia

Up to 10 months
1-2 times per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Collected from delivery until hospital discharge; up to 1 week after birth

What Are the Treatments Tested in This Trial?

Interventions

  • Mitoquinol Mesylate

Trial Overview

The study tests whether MitoQ (a mitochondrial antioxidant) can improve blood vessel function and placental health in women with preeclampsia compared to a placebo. Participants are randomly assigned to receive either MitoQ or an inactive pill.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Preeclampsia without Severe Features taking MitoQExperimental Treatment1 Intervention
Group II: Preeclampsia with Severe Features taking Mitoquinol MesylateExperimental Treatment1 Intervention
Group III: Preeclampsia with Severe Features taking placeboPlacebo Group1 Intervention
Group IV: Preeclampsia without Severe Features taking placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Bill and Melinda Gates Foundation

Collaborator

Trials
428
Recruited
23,060,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32228063/

The Potent Antioxidant MitoQ Protects Against ...

The Potent Antioxidant MitoQ Protects Against Preeclampsia During Late Gestation but Increases the Risk of Preeclampsia When Administered in ...

MitoQ to Improve Vascular Funciton in Preeclampsia

Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve ...

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The trial, supported by a grant from the Gates Foundation through Grand Challenges, is testing whether the supplement MitoQ can improve vascular ...

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After six weeks of supplementation, MitoQ was found to be 24% more effective than CoQ10 at reducing hydrogen peroxide levels in the mitochondria during states ...

MitoQ to Ameliorate Vascular Function in Preeclampsia

Participants will be monitored regularly with a measure of endothelial dysfunction (brachial artery flow-mediated dilation) as primary outcome, and including ...

The Potent Antioxidant MitoQ Protects Against ...

The Potent Antioxidant MitoQ Protects Against Preeclampsia During Late Gestation but Increases the Risk of Preeclampsia When Administered in Early Pregnancy.

Mitochondrial-targeted antioxidant attenuates ...

MitoQ supplementation is a simpler option and provides protection in the present study and other animal models of preeclampsia (22, 98, 100), ...