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

NCT01302704 | Withdrawn

• 1 other identifier: FWH20110003H
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Vitamin D

Keywords

Vitamin D; Proton Pump Inhibitors

Outcome Measures

Primary Outcomes (1)

• Change in 25-OH Vitamin D Blood Levels over 60 days

  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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects less than 18 years of age.
• Subjects that have known malabsorption conditions.
• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, 89191, United States

Location

Study Officials

• Roger Piepenbrink, D.O.

  Michael O'Callaghan Federal Hospital/Nellis Air Force Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 24, 2011
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)