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Vitamin

Vitamin D Prophylaxis for Pre-eclampsia

Phase 4
Waitlist Available
Led By Diana J Garretto, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.

Eligible Conditions
  • Pre-eclampsia
  • HELLP Syndrome
  • Eclampsia
  • Preeclampsia
  • Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vitamin D prophylaxis in pregnant women and incidence of hypertensive disorders of pregnancy
Secondary study objectives
Adverse neonatal outcome in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Cord blood Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Maternal Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin D ProphylaxisExperimental Treatment1 Intervention
Participants will be provided Vitamin D 3000 IU daily or Vitamin D 4000 IU daily with and without concurrent use of prenatal vitamins, respectively.
Group II: No Vitamin D ProphylaxisActive Control1 Intervention
Participants will not receive additional Vitamin D in the pregnancy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
222 Previous Clinical Trials
41,619 Total Patients Enrolled
Diana J Garretto, MDPrincipal InvestigatorSUNY Stony Brook Hospital
~45 spots leftby Nov 2025
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