Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes

NCT ID: NCT04633551

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-05-30

Brief 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. 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.

Conditions

Pre-Eclampsia; Pre-Term; Intrauterine Growth Restriction; Hypertension in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Participants in this arm will receive a commercially available anti-inflammatory supplement.

Group Type: EXPERIMENTAL

Anti-inflammatory supplement

Intervention Type: DIETARY_SUPPLEMENT

commercially available combination of curcumin, quercitin, resveratrol, and green tea

Control

Participants in this arm will not receive a commercially available anti-inflammatory supplement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anti-inflammatory supplement

commercially available combination of curcumin, quercitin, resveratrol, and green tea

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more
• Most recent pregnancy was complicated by an APO

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Abbi Danielle Lane-Cordova

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abbi Lane-Cordova, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

Public Health Research Center

Columbia, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10010335

Identifier Type: -

Identifier Source: org_study_id