1039318- The Hematologic effects of prolonged proton pump inhibitor (PPI) treatment in pediatric patients
The purpose of this research is to determine the effect of prolonged (6 months or more) PPI therapy for extra-esophageal reflux (EER) and/or gastroesophageal reflux disease (GERD) on serum folate, B12, ferritin and iron levels, and RBC microscopic cellular appearance in children ages 0 to 18 years. This study is open until January 13, 2007.

Inclusion criteria:

• Children between the ages of 0 to 18 years meeting criteria of EER disease
• 6 months or great duration of Lansoprazole treatment
• Has had the following test performed by primary care provider after being on Lansoprazole for at least 6 months:
• serum folate
• B12
• ferritin
• iron levels
• RBC microscopic cellular appearance

Exclusion criteria:

• Children with clinically relevant congenital diseases such as sickle cell anemia or other blood dyscrasias which would interfere with analysis, known developmental delays or biochemical deficiencies such as homocystineuria.
• Children diagnosed with failure to thrive or other nutritional abnormality will be excluded.
• Children who are currently on multivitamin with iron will be excluded.

What Is Involved in the Study?

• Patient eligibility determined.
• The legally authorized representative is contacted on behalf of patient for consent for participation in study. A Health Insurance Portability Accountability Act (HIPAA) Authorization and Informed Consent will be reviewed and signed.
• The legally authorized representative will be asked to discuss participation in the study with his/her child if 7 years or older.
• A researcher will then obtain the needed information from your child’s health record.
• Data will be compiled and analyzed.
• Reports, articles and/or presentations will be prepared.

You may ask more questions about the study at any time. You can reach a member of the Outcomes of Pediatric Patients Previously Treated with Proton Pump Inhibitors study by calling 573-884-4112, you may leave a message 24 hours a day. A study staff member will return your call during our regular office hours. We are open Monday through Friday between 8 am and 4 pm CST or contact us by email at info@marci-kids.com.