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NCT04394910

Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)

Completed NA Last updated 6 July 2023
What this trial tests

NA trial testing Pomegranate Juice in Intrauterine Growth Restriction in 103 participants. Completed in 26 February 2022.

Timeline
16 January 2016
Primary endpoint
1 January 2022
26 February 2022

Quick facts

Lead sponsorBrigham and Women's Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment103
Start date16 January 2016
Primary completion1 January 2022
Estimated completion26 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 45, female only, with Intrauterine Growth Restriction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infants diagnosed with intrauterine growth restriction are at increased risk for brain injury in the neonatal period, and eventually increased risk for adverse long-term neurodevelopmental outcomes. This kind of growth restriction is often caused by long-term placental insufficiency leading to chronic lack of oxygen in the brain during development. Pomegranate juice is one of the highest polyphenol-containing dietary supplements commercially available. Previous studies have shown that pomegranate-derived polyphenols are potent neuroprotective antioxidants with no proven side effects. The investigators hypothesize that maternal dietary supplementation with pomegranate juice during the last trimester of pregnancy will reduce the effects of exogenous stimuli contributing to placental insufficiency, and will enhance brain growth and development in the IUGR population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomized controlled trial investigating the impact of maternal dietary supplementation with pomegranate juice on brain injury in infants with IUGR.
    Ross MM, Cherkerzian S, Mikulis ND, Turner D, et al · · 2021 · cited 14× · PMID 33574371 · DOI 10.1038/s41598-021-82144-0

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Other trials of Pomegranate Juice

Trials testing the same drug.

Other recruiting trials for Intrauterine Growth Restriction

Currently open trials in the same condition.

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

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Data sources for this page

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