The Influence of Proton Pump Inhibitors (PPI's) on Blood Levels of 25-Hydroxyvitamin D.
This study is currently recruiting participants.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Mike O'Callaghan Federal Hospital
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302704
First received: February 17, 2011
Last updated: April 19, 2012
Last verified: April 2012
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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.
| Estimated Enrollment: | 65 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302704
Contacts
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC | 7026532756 | jill.teixeira@nellis.af.mil |
| Contact: Roger Piepenbrink, D.O. | 7026532099 | roger.piepenbrink@nellis.af.mil |
Locations
| United States, Nevada | |
| Mike O'Callaghan Federal Hospital | Recruiting |
| Nellis AFB, Nevada, United States, 89191 | |
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 7026532756 jill.teixeira@nellis.af.mil | |
| Principal Investigator: Roger Piepenbrink, D.O. | |
| Sub-Investigator: Paul Crawford, M.D. | |
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: | April 19, 2012 |
| 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 June 17, 2013