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Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR)

NCT00788866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-10-17

No results posted yet for this study

Summary

Infants with intrauterine growth restriction are known to be at increased risk for long term neurodevelopmental delay into adulthood. The main mechanism for this is likely decreased blood flow to the brain secondary to altered placental blood flow. Antioxidants may serve to protect the developing brain from this process. Animal studies have shown that pomegranate juice protects the fetal brain from injury in a model of stroke. This clinical trial is intended to evaluate if giving mothers pomegranate juice during the last several weeks of pregnancy can help protect intrauterine growth restricted babies' brains.

Conditions

  • Intrauterine Growth Restriction

Interventions

DIETARY_SUPPLEMENT

Pomegranate Juice

8 oz of pomegranate juice daily vs placebo juice identical in all respects except pomegranate

DIETARY_SUPPLEMENT

Placebo

Juice that matches the makeup of pomegranate in regards to sugar, vitamin C, etc. The only difference is that it lacks pomegranate juice.

Sponsors & Collaborators

Principal Investigators

  • Michael Nelson, MD, MPH · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00788866 on ClinicalTrials.gov