- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00788866
Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR) (POM-1)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is divided into two separate phases.
Phase I evaluated if the antioxidants produced from pomegranate juice cross the placenta in normal healthy pregnancies. Twenty women were enrolled, 10 who will take 8 oz of pomegranate juice daily and then 10 others who will take 8 oz of placebo juice without pomegranate daily. Blood samples were first collected from the woman at the time enrollment and then from both the woman and the cord blood at the time of delivery. These blood samples were analyzed to measure the levels of antioxidant metabolites from the pomegranate juice. This phase was deigned to confirm placental transfer of antioxidant pomegranate metabolites. The results confirmed placenta transfer of pomegranate metabolites. Further, placental tissues from 12 patients (4 in the pomegranate group and 8 in the control group) were collected for analysis of oxidative stress. The preliminary in vivo results were extended to oxidative stress and cell death assays in vitro. Placental explants and cultured primary human trophoblasts were exposed to pomegranate juice or glucose (control) under defined oxygen tensions and chemical stimuli. We found decreased oxidative stress in term human placentas from women who labored after prenatal ingestion of pomegranate juice compared with apple juice as control. Moreover, pomegranate juice reduced in vitro oxidative stress, apoptosis, and global cell death in term villous explants and primary trophoblast cultures exposed to hypoxia, the hypoxia mimetic cobalt chloride, and the kinase inhibitor staurosporine. Punicalagin, but not ellagic acid, both prominent polyphenols in pomegranate juice, reduced oxidative stress and stimulus-induced apoptosis in cultured syncytiotrophoblasts.
Phase II focuses on pregnancies with intrauterine growth restriction. If they meet entry criteria, then woman will be enrolled and randomized into 1 of 2 groups.
Treatment group: Expecting mothers in this group will start a daily regimen of 8 oz glass of pomegranate juice. They will keep a daily diary documenting their compliance. They will continue this daily intake up until delivery of their infant.
Placebo group: These women will start a daily regimen of an 8 oz of pomegranate free juice placebo that matches taste, calories, and appearance to regular pomegranate juice but lacks polyphenols. They will also keep a diary of daily intake to help ensure compliance similar to the treatment group. They too will continue to take the placebos up until the time they deliver.
Both groups: All women will be followed up on a weekly basis to assess compliance. A detailed diet history will be collected from the women at the time of enrollment, midway through the 3rd trimester and at the time of delivery. Furthermore, all women will have a detailed social history collected at the time of enrollment. Upon delivery, cord blood will be collected and sent for ellagic acid, a polyphenic component. All placental material will be sent for formal pathological exam and analyzed for markers of placental injury.
If clinically stable, the infants will receive MRI evaluations to evaluate for possible brain injury.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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St Louis, Missouri, United States, 63110
- St Louis Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Phase I:
Inclusion Criteria:
- Healthy expecting mothers two weeks from their expected due dates
- No evidence of IUGR
- No evidence of fetal problems
Phase II:
Inclusion Criteria:
- Expecting mother with a fetal diagnosis of intrauterine growth restriction (IUGR) defined by estimated fetal weight <10th percentile for gestational age
- 24 - 34 weeks gestation
Exclusion Criteria:
- Major congenital abnormalities
- Known fetal chromosomal disorder
- Maternal illicit drug use
- Maternal IV and Hepatitis C infection
- Premature rupture of membranes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pomegranate juice
This arm with receive 8oz of pomegranate juice per day.
|
8 oz of pomegranate juice daily vs placebo juice identical in all respects except pomegranate
|
Placebo Comparator: Placebo
This group will take 8oz of placebo juice that lacks pomegranate daily
|
Juice that matches the makeup of pomegranate in regards to sugar, vitamin C, etc.
The only difference is that it lacks pomegranate juice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CNS injury at term by MR Imaging
Time Frame: 36 - 41 weeks (post delivery)
|
|
36 - 41 weeks (post delivery)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Birth weight
Time Frame: At birth
|
At birth
|
Gestational age at delivery
Time Frame: At birth
|
At birth
|
Placental morphology: weight and size
Time Frame: At birth
|
At birth
|
Ellagic acid levels from cord blood
Time Frame: To discharge
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To discharge
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Dubowitz neurologic exam at term
Time Frame: To discharge
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To discharge
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Time to full oral feeds
Time Frame: To discharge
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To discharge
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ROP
Time Frame: To discharge
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To discharge
|
NEC
Time Frame: To discharge
|
To discharge
|
Length of ventilatory support
Time Frame: To discharge
|
To discharge
|
Time to discharge
Time Frame: To discharge
|
To discharge
|
Placental micrography: number of villi, vasculature, collagen content
Time Frame: At birth
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At birth
|
Placental immunohistochemistry: proliferation, apoptosis and differentiation
Time Frame: At birth
|
At birth
|
Placental: immunoassays: HSP90, lipid hydroperoxide, nitrotyrosine assay, paraoxonase 1 expression, superoxide dismutases
Time Frame: At birth
|
At birth
|
Placental RNA microarray
Time Frame: At birth
|
At birth
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Umbilical cord gases
Time Frame: At birth
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At birth
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Pregnancy complications: preeclampsia
Time Frame: At birth
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At birth
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Neonatal wellbeing: APGAR scores, need for resuscitation
Time Frame: At birth
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At birth
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal compliance
Time Frame: To delivery
|
|
To delivery
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Analysis both by 'intention to treat' and 'as treated'
Time Frame: To discharge
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To discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Nelson, MD, MPH, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pomegranate-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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