Clinical trial NCT04633551: Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Official title: Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Pre-Term
Intrauterine Growth Restriction
Hypertension in Pregnancy
Keywords: adverse pregnancy outcome
inflammation
vascular health
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood Pressure (mmHg)
timeFrame: 1 month
measure: Arterial Stiffness (m/s)
timeFrame: 1 month
measure: Augmentation Index (%)
timeFrame: 1 month
measure: Endothelial Function (Reactive Hyperemia)
timeFrame: 1 month
Secondary outcomes:
measure: Inflammatory Vascular Biomarkers (pg/dL)
timeFrame: 1 month
measure: Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)
timeFrame: 1 month
measure: Perception of Intervention (15-20 Minute Interview)
timeFrame: 1 month
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Public Health Research Center
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Abbi Lane-Cordova, PhD
role: PRINCIPAL_INVESTIGATOR
References: