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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302704
First Posted: February 24, 2011
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
  Purpose
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
Vitamin D

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: The Influence of Proton Pump Inhibitors (PPI's) on Blood Levels of 25-Hydroxyvitamin D.

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: April 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

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.
Criteria

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
  Contacts and Locations
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


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

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302704     History of Changes
Other Study ID Numbers: FWH20110003H
First Submitted: February 17, 2011
First Posted: February 24, 2011
Last Update Posted: November 25, 2013
Last Verified: November 2013

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

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


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