Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633551
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-11-06
Brief Title:
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIA
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 womens 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 n28 or a standard care group n28 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 ie Cohens d050 and accepting a β080 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 dosesday 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 ie 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 participants perceptions of supplementation with a brief interview at the final visit Interviews will capture participants 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
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 dosesday 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 ie 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 participants perceptions of supplementation with a brief interview at the final visit Interviews will capture participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None