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Proton Pump Inhibitor Therapy and Bone Density in Premature Infants

NCT00888017 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2013-01-23

No results posted yet for this 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.

Conditions

  • Osteopenia
  • Prematurity

Sponsors & Collaborators

Principal Investigators

  • Gary M Chan, MD · University of Utah

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888017 on ClinicalTrials.gov