Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- serum vitamin B12
研究概览
简要总结
This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.
详细描述
Subjects had serum creatinine <1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60-89 years
- •PPI use for >12 months (PPI group)
- •no PPI use for 30 days prior to arm 1
- •long term care resident
排除标准
- •pernicious anemia
- •severe megaloblastic anemia
- •free-living
- •serum creatinine > 1.8 mg/dL
研究组 & 干预措施
1
Comparison of serum vitamin and B12 concentrations of PPI and non-PPI groups
干预措施: blood collection (Other)
2
Comparison of baseline and end of treatment serum vitamin B12 and MMA concentrations.
干预措施: treatment (cyanocobalamin nasal spray) (Drug)
结局指标
主要结局
serum vitamin B12
时间窗: baseline and after 8 weeks of treatment
serum methylmalonic acid (MMA)
时间窗: at baseline and after eight weeks of treatment
次要结局
未报告次要终点