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Pomegranate Juice for Intrauterine Growth Restriction

N/A
Waitlist Available
Led By Terrie E Inder, MD, MBChB
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Expecting mother with a fetal diagnosis of less than 5th percentile on the Doubilet fetal growth curve
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the bayley iii exam will be administered at a one-time visit scheduled between 18-36 months.
Awards & highlights

Study Summary

This trial is testing whether pomegranate juice can help protect babies' brains who are at risk for brain injury due to intrauterine growth restriction.

Eligible Conditions
  • Intrauterine Growth Restriction

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the bayley iii exam will be administered at a one-time visit scheduled between 18-36 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the bayley iii exam will be administered at a one-time visit scheduled between 18-36 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diffusion tensor imaging measures of fractional anisotropy (FA), and mean (MD), radial (RD), and axial (AD) diffusivity from infant term equivalent brain MRI.
Infant brain injury assessed on term-equivalent brain magnetic resonance image (MRI) using the Kidokoro injury scoring system.
Total and regional infant brain volumes assessed on term equivalent brain MRI using MANTiS.
Secondary outcome measures
Cognitive, motor, and language neurodevelopment scores on the Bayley III exam.
Maternal compliance with juice regimen.
Other outcome measures
Cord gas characteristics.
Gestational age at delivery.
Incidence of pre-eclampsia.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pomegranate JuiceExperimental Treatment1 Intervention
Dietary supplementation with 8 oz. commercially-available pomegranate juice consumed daily.
Group II: Placebo JuicePlacebo Group1 Intervention
Dietary supplementation with 8 oz. placebo juice (identical to pomegranate juice but lacking polyphenols) consumed daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomegranate Juice
2014
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,264,605 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,727 Total Patients Enrolled
POM Wonderful LLCIndustry Sponsor
14 Previous Clinical Trials
1,623 Total Patients Enrolled

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
Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)
Terrie Inder 2016. "Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04394910.
~11 spots leftby Apr 2025
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