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Vitamin

Vitamin D Prophylaxis for HELLP Syndrome

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

Study Summary

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vitamin D prophylaxis in pregnant women and incidence of hypertensive disorders of pregnancy
Secondary outcome measures
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

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
216 Previous Clinical Trials
39,559 Total Patients Enrolled
Diana J Garretto, MDPrincipal InvestigatorSUNY Stony Brook Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy
2016. "A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02920593.
All > Pregnancy > Vitamin D
~48 spots leftby Apr 2025
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