Evaluation of the Effects of Lansoprazole Usage on Bone Turnover Markers in Children With Gastroesophageal Reflux or Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measuring serum calcium levels
研究概览
简要总结
Use of proton pump inhibitors (PPI) has increased in recent years. There are concerns that PPIs have possible negative effects on bone metabolism. It has been suggested that PPIs may reduce the absorption of calcium from the small intestine and lead to bone resorption by affecting osteoclastic activity. In this study, it is planned to investigate the effects of lansoprazole, a proton pump inhibitor, on bone turnover markers in pediatric patients with gastroesophageal reflux or gastroesophageal reflux disease.
详细描述
This study is planned to be conducted with children who are diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 2-18 years and healthy volunteers. The diagnosis of gastroesophageal reflux will be made in accordance with the guidelines of North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). Written and verbal consent will be obtained from patients/healthy volunteers and/or parents who want to participate in the study. Serum calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin and urine calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen levels will be measured at baseline and second month in study group and once in control groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.
排除标准
- •Patients with a malabsorptive disease.
- •Patients with any chronic disease.
- •Patients who use any medication that may affect calcium and bone metabolism.
- •Patients who used proton pumps inhibitor within the last 3 months.
- •Patients who do not use lansoprazole in the study group.
- •Patients whose blood and urine samples are not taken in the eighth week of treatment.
结局指标
主要结局
Measuring serum calcium levels
时间窗: First day
Measuring serum calcium levels with spectrophotometric method (mg/dL).
Measuring serum osteocalcin levels
时间窗: First day
Measuring serum osteocalcin levels with spectrophotometric method (mg/L).
Measuring serum parathyroid hormone levels
时间窗: First day
Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).
Measuring serum magnesium levels
时间窗: First day
Measuring serum magnesium levels with spectrophotometric method (mg/dL).
Measuring serum vitamin D levels
时间窗: First day
Measuring serum vitamin D with immunoassay method (ng/mL).
Measuring spot urine calcium levels
时间窗: First day
Measuring urine calcium levels with spectrophotometric method (mg/dL).
Measuring urine creatinine levels
时间窗: First day
Measuring urine creatinine levels with spectrophotometric method (mg/dL).
Measuring serum alkaline phosphatase levels
时间窗: First day
Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).
Measuring urine deoxypyridinoline levels
时间窗: First day
Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).
Measuring urine N-terminal telopeptides Type I collagen levels
时间窗: First day
Measuring urine N-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).
Measuring urine C-terminal telopeptides Type I collagen levels
时间窗: First day
Measuring urine C-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).
次要结局
未报告次要终点
研究者
Ali Islek
Associate Professor
Ataturk University