Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Condition: Pre-Eclampsia; Pre-Term; Intrauterine Growth Restriction; Hypertension in Pregnancy
MeSH terms: Eclampsia; Pre-Eclampsia; Fetal Growth Retardation; Hypertension, Pregnancy-Induced; Inflammation
Study type: Interventional

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.
    

Intervention name(s): Anti-inflammatory supplement
Intervention type(s): Dietary Supplement
Intervention description(s): commercially available combination of curcumin, quercitin, resveratrol, and green tea
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adverse pregnancy outcome; inflammation; vascular health