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NCT00888017 · ClinicalTrials.gov registry record

Proton Pump Inhibitor Therapy and Bone Density in Premature Infants

A clinical trial, sponsored by University of Utah.

Terminated
Registry status
10
Enrollment target

NCT00888017: Clinical Trial study, sponsored by University of Utah.

NCT00888017 is a clinical trial that was terminated before completion, run by University of Utah. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00888017 was terminated before completion, sponsored by University of Utah.

TERMINATED
Registry status
10 participants
Enrollment target

Study Summary

Previous research studies have shown that there may be a connection between proton pump inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux medications raise the pH of the stomach, which may effect the body's ability to absorb certain calcium compounds. Neonates are at a crucial age for bone mineralization. Because esophageal reflux is common in neonates, PPI therapy is commonly used, despite little information on effectiveness and side effects. PPIs work by blocking the production of protons in the pumps in the stomach, thus making the stomach less acidic. The calcium ion needs an acidic environment in order to be broken down from its natural compounds into an absorbable form (2). This is troubling because of the problems associated with osteopenia in neonates. Bone mineralization is important for premature infants. Rickets and bone fractures are higher in preterm infants than term infants. For this reason, we are investigating whether there is a connection between PPI therapies (specifically Prevacid) and decreased bone densities in neonates. The objective is to determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-04
Est. Completion 2013-01
University of Utah

818 total trials

Why NCT00888017 stopped before completion

NCT00888017 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00888017 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00888017 about?

NCT00888017 is a clinical study titled "Proton Pump Inhibitor Therapy and Bone Density in Premature Infants". Previous research studies have shown that there may be a connection between proton pump inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux medications raise the pH of the stomach, which may effect the body's ability to absorb certain calcium compounds. Neonates are...

What is the current status of trial NCT00888017?

This trial is currently terminated. The enrollment target is 10 participants. The study started on 2009-04. Estimated completion is 2013-01.

Who is sponsoring clinical trial NCT00888017?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00888017, the US trial registry maintained by the National Library of Medicine. NCT00888017 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.