The Influence of Proton Pump Inhibitors (PPI's) on Blood Levels of 25-Hydroxyvitamin D.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in 25-OH Vitamin D Blood Levels over 60 days
研究概览
简要总结
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).
详细描述
Subjects (DoD beneficiaries) will be recruited from all male and female subjects whom are at least 18 years of age and are Nellis Air Force Base dependents or retirees. A total of 65 subjects will be recruited.
Screening Visit:
- Obtain signed Informed Consent document and HIPAA Authorization
- Women of child bearing potential will have a serum pregnancy test (approximately 1-2 teaspoons of blood)
- 25-OH Vitamin D baseline levels will be drawn via 1 venipuncture (approximately 1-2 teaspoons of blood)
Visit 1 (within 1 week of screening visit):
• Subjects will be prescribed oral omeprazole 20mg (a proton pump inhibitor) by one of the Investigators. Subject will take oral omeprazole 20mg for 60 consecutive days.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in 25-OH Vitamin D Blood Levels over 60 days
时间窗: 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.
次要结局
未报告次要终点