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NCT00925925 · ClinicalTrials.gov registry record
Epigenetic Markers of B-Cell Function in Low Birth Weight Infants
A clinical trial, sponsored by University of Utah.
- Completed
- Registry status
- 64
- Enrollment target
NCT00925925 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 64 participants.
The verdict
NCT00925925 has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 64 participants
- Enrollment target
Study Summary
Low birth weight (LBW) status (\< 10% for gestational age at birth) is associated with increased risk for diseases such as type II diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease in adults, and represents one example of the "fetal onset of adult disease" hypothesis. Recent data strongly associates LBW status with impaired innate and adaptive immunity leading to increased risk for severe infections during adolescence or early adulthood. Animal studies suggest that the ratio of certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in immunity occur. This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood of infants born LBW in the late preterm to term gestations (\> 34 weeks at birth) and compare those ratios with those of normal birth weight (NBW) controls in a nested case control study design. Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that the regulatory regions controlling their expression are epigenetically vulnerable. The investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and determine whether epigenetic changes to the regulatory regions of the genes coding for CD5 and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the lymphocytes from NBW infants. This proposal will be the first human study to examine epigenetic determination of a maladaptive phenotype following LBW status at birth in a specific cell type leading to a specific impairment of innate and adaptive immunity.
Interventions
- OTHER Cord blood collection for analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00925925
The ClinicalTrials.gov registry entry for NCT00925925 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cord blood collection for analysis is the first listed.
NCT00925925 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00925925 about?
NCT00925925 is a clinical study titled "Epigenetic Markers of B-Cell Function in Low Birth Weight Infants". Low birth weight (LBW) status (\< 10% for gestational age at birth) is associated with increased risk for diseases such as type II diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease in adults, and represents one example of the "fetal onset of adult dis...
What is the current status of trial NCT00925925?
This trial is currently completed. The enrollment target is 64 participants. The study started on 2009-06. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00925925?
The interventions under investigation include: Cord blood collection for analysis (OTHER).
Who is sponsoring clinical trial NCT00925925?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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