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The Influence of Proton Pump Inhibitors (PPI's) on Blood Levels of 25-Hydroxyvitamin D.

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ClinicalTrials.gov Identifier: NCT01302704
Recruitment Status : Withdrawn
First Posted : February 24, 2011
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

Brief Summary:
The purpose of this study is to demonstrate if Proton Pump Inhibitors (PPI's) decrease blood levels of 25-Hydroxyvitamin D (25-OH Vitamin D).

Condition or disease
Vitamin D

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: The Influence of Proton Pump Inhibitors (PPI's) on Blood Levels of 25-Hydroxyvitamin D.
Study Start Date : April 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in 25-OH Vitamin D Blood Levels over 60 days [ Time Frame: 2 years ]
    Subjects will have their baseline 25-OH Vitamin D levels drawn. They will then take Omeprazole 20mg for 60 consecutive days, then have blood samples drawn to measure their 25-OH Vitamin D.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are recruiting healthy volunteers (DoD beneficiaries) whom are at least 18 years of age from the Nellis Air Force Base population. Subjects will not have any concomitant medical conditions, been diagnosed with any chronic illness that requires regular monitoring by a health care provider, have been living in Las Vegas for at least 3 months, and not be on any medications. Some subjects may be the PI or AI's patients. No special populations will be recruited.

Inclusion Criteria:

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • Male and Female (DoD beneficiaries) at least 18 years of age and have lived in the Las Vegas area for at least 3 months.

Exclusion Criteria:

  • Subjects less than 18 years of age.
  • Subjects that have known malabsorption conditions.
  • 25-OH Vitamin D less than 10
  • Pregnancy
  • Non English speaking
  • Taking any prescription medication or over the counter antacids
  • Vitamin d supplements (excluding multivitamin supplements due to relatively low dose of vitamin D)
  • Any medical condition that requires regular monitoring by health care provider

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302704

United States, Nevada
Mike O'Callaghan Federal Hospital
Nellis AFB, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Principal Investigator: Roger Piepenbrink, D.O. Michael O'Callaghan Federal Hospital/Nellis Air Force Base

Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01302704     History of Changes
Other Study ID Numbers: FWH20110003H
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Mike O'Callaghan Military Hospital:
Vitamin D
Proton Pump Inhibitors

Additional relevant MeSH terms:
Proton Pump Inhibitors
Vitamin D
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents