VIA: Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes

Sponsor

University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT04633551

Collaborator

(none)

Enrollment

Location

Arms

8.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia Pre-Term Intrauterine Growth Restriction Hypertension in Pregnancy	Dietary Supplement: Anti-inflammatory supplement	N/A

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

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants in this arm will receive a commercially available anti-inflammatory supplement.	Dietary Supplement: Anti-inflammatory supplement commercially available combination of curcumin, quercitin, resveratrol, and green tea
No Intervention: Control Participants in this arm will not receive a commercially available anti-inflammatory supplement.

Arm

Intervention/Treatment

Experimental: Intervention

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

Dietary Supplement: Anti-inflammatory supplement

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

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Blood pressure (mmHg) [1 month]
Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure
Arterial stiffness (m/s) [1 month]
Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate
Augmentation index (%) [1 month]
Applanation tonometry will be used to describe systolic blood pressure augmentation
Endothelial function (reactive hyperemia) [1 month]
Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion

Secondary Outcome Measures

Inflammatory vascular biomarkers (pg/dL) [1 month]
concentrations of circulating adhesion molecules ICAM and VCAM
Acceptability of intervention (Likert scales from 1-5; not likely at all to extremely likely and free text fields) [1 month]
Surveys regarding opinion and likelihood of taking supplements
Perception of intervention (15-20 minute interview) [1 month]
Interviews will be used to determine barriers and facilitators of adherence.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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