Vitamin D for Preeclampsia

(PROVIDE Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Antipsychotics, others

Disqualifiers: Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 months

200 Participants Needed

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.

Research Team

Eynav Accortt, PhD

Principal Investigator

Cedars Sinai Medical Center Department of OBGYN

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.

Patient at Cedars Sinai Medical Center, Los Angeles, CA

I am female.

Exclusion Criteria

I have never been diagnosed with psychosis.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mental health screening, education, and referral intervention

5 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum assessments at 4 weeks and 3 months

3 months

2 visits (in-person)

Treatment Details

Interventions

• Mental Health Screening, Education and Referral Program

Trial Overview 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.

Participant Groups

Group I: Mental Health Screening Education and Referral Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Maternal Mental Health NOW

Collaborator

Trials

2

Recruited

350+