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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302704
First received: February 17, 2011
Last updated: November 21, 2013
Last verified: November 2013
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302704     History of Changes
Other Study ID Numbers: FWH20110003H
Study First Received: February 17, 2011
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 21, 2014