Vitamin D for Preeclampsia
(PROVIDE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEynav Accortt, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D in reproductive aged women, and its association with preeclampsia and depression. Findings will have substantial impact providing new information implicated in the development of preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive fluid, and kidney stress) and postpartum depression (after birth). Additionally, the study is designed to understand how early mental health screening and evaluation can help pregnant women reduce their risk of developing postpartum depression. Testing the acceptability and effectiveness of this mental health screening, education and referral program at Cedars-Sinai Medical Center will provide valuable patient centered qualitative and quantitative data that can be used in future services planning. The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.

Eligibility Criteria

This trial is for pregnant women aged 18 or older, patients at Cedars Sinai Medical Center in Los Angeles, between 20-40 weeks of gestation (mainly recruited at the start of the third trimester), who prefer English or Spanish.

Inclusion Criteria

I am pregnant and between 20 to 40 weeks along, mostly in my third trimester.

I prefer to communicate in English or Spanish.

I am at least 18 years old.

+2 more

Exclusion Criteria

I have never been diagnosed with psychosis.

Current substance abuse (evident either via medical intake, or in clinical assessment - SCID)

Participant Groups

The study investigates vitamin D's anti-inflammatory effects on preeclampsia and depression during pregnancy. It also tests a mental health screening, education, and referral program to prevent postpartum depression.

1Treatment groups

Experimental Treatment

Group I: Mental Health Screening Education and ReferralExperimental Treatment1 Intervention

Investigators will prospectively assign all 200 women to this screening, education and referral intervention, without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. The health-related intervention, in this case, is an educational program and related process-of-care changes.