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Vitamin D for Preeclampsia (PROVIDE Trial)

N/A

Waitlist Available

Led By Eynav Accortt, PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum 18 years of age

Female

Must not have

Any diagnosis of psychosis, past or current (evident by either meds taken via medical intake, or in clinical assessment - SCID)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to investigate how vitamin D affects inflammation in pregnant women, and whether it's linked to preeclampsia or depression.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on screenings and educational programs rather than medication, there are no direct side effects from interventions. However, learning about potential health risks could cause stress or anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been diagnosed with psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression Diagnosis

Depressive symptoms

Secondary study objectives

Acceptability of Mental Health Program

Anxiety symptoms

Benefits of Mental Health Program

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met