NCT00788866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

5.8 years

First QC Date

November 10, 2008

Last Update Submit

October 16, 2014

Conditions

Intrauterine Growth Restriction

Keywords

NeuroprotectionAntioxidantsNeonatal brain injuryPomegranate juice

Outcome Measures

Primary Outcomes (1)

  • CNS injury at term by MR Imaging

    1. Qualitative MRI injury- white matter injury (WMI) and gray matter injury (GMI) 2. Brain Metrics on MR imaging 3. Diffusion- apparent diffusion coefficient (ADC) and fractional anisotropy (FA) 4. Spectroscopy- lactate and NAA levels in the basal ganglia 5. Advanced MRI development indices - brain volumes, surface based morphology (SBM, folding indices)

    36 - 41 weeks (post delivery)

Secondary Outcomes (17)

  • Placental morphology: weight and size

    At birth

  • Gestational age at delivery

    At birth

  • Birth weight

    At birth

  • Ellagic acid levels from cord blood

    To discharge

  • Dubowitz neurologic exam at term

    To discharge

  • +12 more secondary outcomes

Other Outcomes (2)

  • Maternal compliance

    To delivery

  • Analysis both by 'intention to treat' and 'as treated'

    To discharge

Study Arms (2)

Pomegranate juice

EXPERIMENTAL

This arm with receive 8oz of pomegranate juice per day.

Dietary Supplement: Pomegranate Juice

Placebo

PLACEBO COMPARATOR

This group will take 8oz of placebo juice that lacks pomegranate daily

Dietary Supplement: Placebo

Interventions

Pomegranate JuiceDIETARY_SUPPLEMENT

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

Pomegranate juice
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy expecting mothers two weeks from their expected due dates
  • No evidence of IUGR
  • No evidence of fetal problems
  • Phase II:
  • Expecting mother with a fetal diagnosis of intrauterine growth restriction (IUGR) defined by estimated fetal weight \<10th percentile for gestational age
  • weeks gestation

You may not qualify if:

  • Major congenital abnormalities
  • Known fetal chromosomal disorder
  • Maternal illicit drug use
  • Maternal IV and Hepatitis C infection
  • Premature rupture of membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Matthews LG, Smyser CD, Cherkerzian S, Alexopoulos D, Kenley J, Tuuli MG, Nelson DM, Inder TE. Maternal pomegranate juice intake and brain structure and function in infants with intrauterine growth restriction: A randomized controlled pilot study. PLoS One. 2019 Aug 21;14(8):e0219596. doi: 10.1371/journal.pone.0219596. eCollection 2019.

    PMID: 31433809DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Nelson, MD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations

US(1)