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Completed

NCT Number: NCT00582972

Does Omeprazole Decrease Intestinal Calcium Absorption?

The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

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Key information

About this study

Existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secondary outcomes include the change in urine n-telopeptide.

We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three calcium absorption studies. The first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg of omeprazole daily for 30 days. Women will present to the research unit in the early morning and receive an oral and intravenous calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During the first stay, we will measure each subject's gastric pH by collecting gastric fluid from a temporary nasogastric tube. In consenting subjects we will collect one tube of blood, isolate its DNA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women at least 5 years past menopause, defined as the last date of menses

Exclusion criteria

  • Allergy/Intolerance to orange juice
  • Allergy/Intolerance to omeprazole or other PPI therapy
  • Use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin & tacrolimus
  • Use of antacids, PPI or H2-blocker therapy within the past two months
  • Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's Disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
  • Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute
  • Use of medications known to interfere with calcium metabolism, including oral steroids or anticonvulsants

Treatment and study plan

Omeprazole

Drug

40 mg po qAM one-half hour before breakfast for 30 days

Other names: Losec, Prilosec

Primary outcomes

  1. Change in Intestinal Calcium Absorption From Baseline to One Month

    Time frame: change in calcium absorption from baseline to 1 month

    percent calcium absorption

Secondary outcomes

  1. Change in Bone Resorption From Baseline to 1 Month

    Time frame: change in bone resorption from baseline to 1 month

    urine n-telopeptide (normalized to creatinine levels)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Dec 28, 2007
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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