Pre-EclampsiaVIANCT04633551
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
A study testing Anti-inflammatory supplement in people with Pre-Eclampsia and Pre-Term, run by University of South Carolina at 1 site in United States.
Trial summary
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Pre-Term, Intrauterine Growth Restriction
- What is being tested?
- Anti-inflammatory supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more
- Most recent pregnancy was complicated by an APO
Who cannot join
- currently pregnant or breastfeeding,
- current smoking,
- active cancer,
- regular use of NSAIDs, steroidal medications, statins, or other anti-inflammatory supplements,
- HIV/AIDS,
- uncontrolled high blood pressure ( >160/>110 mmHg),
- unwilling or unable to use a dietary supplement,
- known sensitivity to resveratrol, curcumin, green tea, or quercetin
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Research Center
Columbia, South Carolina, 29208
About this study
Official title: Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Investigators will randomize women who had an APO in the past 3 years to receive an anti-inflammatory supplement or serve as a time control. Investigators will compare blood pressure, arterial stiffness, blood vessel reactivity, and blood markers of inflammation between women who did and did not receive the supplement. Investigators will determine women's attitudes about taking a dietary supplement and measure whether the participants who receive the supplement take all or most of the doses.
Read the detailed description
Research Design. Investigators will invite 56 women with an APO within the past 3 yrs to participate. Women will be randomly assigned to the 4-wk intervention group (n=28) or a standard care group (n=28) using a computerized random number generator, stratified by race. Assuming up to 25% with poor adherence, Investigators expect that 42 women (21 each arm) will complete the study. No data exist related to effects of supplementation on vascular function in our population, we assumed a medium effect size, i.e. Cohen's d~0.50 and accepting a β=0.80, to generate sample sizes. Generation of effect sizes is a key outcome of this study. Investigators will conduct a vascular assessment and blood draw at two visits: before the intervention begins and within 3 days of completing the intervention. Investigators will conduct visits during the early follicular phase of menstrual cycle to account for fluctuating hormones. Vascular testing will be performed in the supine position and ≥4 hours after a light meal. Surveys for Aim 2 will be completed within the first 2 weeks of study enrollment, and interviews for Aim 2 will be conducted at the end of Visit 2.
Anti-inflammatory supplementation intervention. Participants randomized to the supplementation intervention will receive a commercially available supplement (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene). Participants will be asked to take 2 doses/day (1g total). Participants randomized to supplementation will receive a daily email reminding them to take the supplement. Covariates. Medical history, age, and sociodemographics will be obtained via self-report. Investigators will use validated surveys to determine physical activity, sedentary behavior, and smoking history. Height and weight will be measured.
Acceptability of Dietary Supplementation. Investigators will administer surveys to all participants to understand their perceptions of dietary supplementation, including potential benefits and consequences associated with supplementation. Investigators will determine willingness to use supplements, barriers to supplementation, and who, i.e., physician or partner, influences their decision to use dietary supplements.
Adherence and Barriers to Adherence. Investigators will count pills to determine adherence to supplementation regime. Investigators will assess each intervention participant's perceptions of supplementation with a brief interview at the final visit. Interviews will capture participant's perceptions of the role of supplementation for CVD prevention, and any side effects of supplementation. Investigators will ask participants to recommend ways to encourage participation and ask questions regarding their perceptions of the incentive structure and contact with the study team. Investigators will contact participants who drop out of the study to identify reasons for drop out.
- Being tested
- Anti-inflammatory supplement
- Keywords
- adverse pregnancy outcome, inflammation, vascular health
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Fetal Growth Retardation, Hypertension, Pregnancy-Induced, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory supplementDietary supplement
commercially available combination of curcumin, quercitin, resveratrol, and green tea
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this arm will receive a commercially available anti-inflammatory supplement. Receives: Dietary Supplement: Anti-inflammatory supplement |
| Control | No intervention | Participants in this arm will not receive a commercially available anti-inflammatory supplement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (mmHg)
Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure
Measured: 1 month
Arterial Stiffness (m/s)
Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate
Measured: 1 month
Augmentation Index (%)
Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.
Measured: 1 month
Endothelial Function (Reactive Hyperemia)
Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion
Measured: 1 month
Secondary outcomes (3)
Inflammatory Vascular Biomarkers (pg/dL)
concentrations of circulating adhesion molecules ICAM and VCAM
Measured: 1 month
Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)
Surveys regarding opinion and likelihood of taking supplements. Here we report the number of participants who thought supplements were somewhat or extremely useful (Likert score of 4-5) for improving health.
Measured: 1 month
Perception of Intervention (15-20 Minute Interview)
Interviews will be used to determine barriers and facilitators of adherence. We report number of participants who were happy with contact with study team for adherence reminders.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbi Danielle Lane-Cordova, University of South Carolina
- Investigators
- Abbi Lane-Cordova, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633551
- Sponsor's protocol ID
- 10010335
- Acronym
- VIA
- Status last verified
- Sep 2023
- First submitted
- 6 Nov 2020
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will disseminate results at conferences and in medical journals. We are open to sharing limited datasets upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT04633551
- Acronym / sponsor ID
- VIA / 10010335
- Keywords
- adverse pregnancy outcome, inflammation, vascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Investigators will randomize women who had an APO in the past 3 years to receive an anti-inflammatory supplement or serve as a time control. Investigators will compare blood pressure, arterial stiffness, blood vessel reactivity, and blood markers of inflammation between women who did and did not receive the supplement. Investigators will determine women's attitudes about taking a dietary supplement and measure whether the participants who receive the supplement take all or most of the doses.
Detailed description
Research Design. Investigators will invite 56 women with an APO within the past 3 yrs to participate. Women will be randomly assigned to the 4-wk intervention group (n=28) or a standard care group (n=28) using a computerized random number generator, stratified by race. Assuming up to 25% with poor adherence, Investigators expect that 42 women (21 each arm) will complete the study. No data exist related to effects of supplementation on vascular function in our population, we assumed a medium effect size, i.e. Cohen's d~0.50 and accepting a β=0.80, to generate sample sizes. Generation of effect sizes is a key outcome of this study. Investigators will conduct a vascular assessment and blood draw at two visits: before the intervention begins and within 3 days of completing the intervention. Investigators will conduct visits during the early follicular phase of menstrual cycle to account for fluctuating hormones. Vascular testing will be performed in the supine position and ≥4 hours after a light meal. Surveys for Aim 2 will be completed within the first 2 weeks of study enrollment, and interviews for Aim 2 will be conducted at the end of Visit 2.
Anti-inflammatory supplementation intervention. Participants randomized to the supplementation intervention will receive a commercially available supplement (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene). Participants will be asked to take 2 doses/day (1g total). Participants randomized to supplementation will receive a daily email reminding them to take the supplement. Covariates. Medical history, age, and sociodemographics will be obtained via self-report. Investigators will use validated surveys to determine physical activity, sedentary behavior, and smoking history. Height and weight will be measured.
Acceptability of Dietary Supplementation. Investigators will administer surveys to all participants to understand their perceptions of dietary supplementation, including potential benefits and consequences associated with supplementation. Investigators will determine willingness to use supplements, barriers to supplementation, and who, i.e., physician or partner, influences their decision to use dietary supplements.
Adherence and Barriers to Adherence. Investigators will count pills to determine adherence to supplementation regime. Investigators will assess each intervention participant's perceptions of supplementation with a brief interview at the final visit. Interviews will capture participant's perceptions of the role of supplementation for CVD prevention, and any side effects of supplementation. Investigators will ask participants to recommend ways to encourage participation and ask questions regarding their perceptions of the incentive structure and contact with the study team. Investigators will contact participants who drop out of the study to identify reasons for drop out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Anti-inflammatory supplementParticipants in this arm will receive a commercially available anti-inflammatory supplement. |
| Control | No intervention | –Participants in this arm will not receive a commercially available anti-inflammatory supplement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more
- Most recent pregnancy was complicated by an APO
Key exclusion criteria (8 listed)
- currently pregnant or breastfeeding,
- current smoking,
- active cancer,
- regular use of NSAIDs, steroidal medications, statins, or other anti-inflammatory supplements,
- HIV/AIDS,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-inflammatory supplementcommercially available combination of curcumin, quercitin, resveratrol, and green tea | Dietary supplement | Intervention |
Primary outcome
Blood Pressure (mmHg)
Time frame: 1 month
Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure
Arterial Stiffness (m/s)
Time frame: 1 month
Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate
Augmentation Index (%)
Time frame: 1 month
Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.
Endothelial Function (Reactive Hyperemia)
Time frame: 1 month
Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion
3 secondary outcomes
Inflammatory Vascular Biomarkers (pg/dL)
Time frame: 1 month
Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)
Time frame: 1 month
Perception of Intervention (15-20 Minute Interview)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will disseminate results at conferences and in medical journals. We are open to sharing limited datasets upon request.
Related trials for Pre-Eclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbi Lane-Cordova, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory supplement in people with Pre-Eclampsia and Pre-Term, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (mmHg) (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.