Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04633551 |
Other study ID # |
10010335 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
May 30, 2022 |
Study information
Verified date |
September 2023 |
Source |
University of South Carolina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.