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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
Blood and urine samples will be taken at baseline and at the end of the second month. For this purpose, 5 ml of blood samples will be taken to plain blood tubes for evaluation of calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin quantities. And 3 ml of urine for calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen.
Ataturk University Hospital
Erzurum, Turkey (Türkiye)
Measuring serum calcium levels
Measuring serum calcium levels with spectrophotometric method (mg/dL).
Time frame: First day
Measuring serum alkaline phosphatase levels
Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L).
Time frame: First day
Measuring serum magnesium levels
Measuring serum magnesium levels with spectrophotometric method (mg/dL).
Time frame: First day
Measuring serum osteocalcin levels
Measuring serum osteocalcin levels with spectrophotometric method (mg/L).
Time frame: First day
Measuring serum parathyroid hormone levels
Measuring serum parathyroid hormone levels with immunoassay method (pg/mL).
Time frame: First day
Measuring serum vitamin D levels
Measuring serum vitamin D with immunoassay method (ng/mL).
Time frame: First day
Measuring urine deoxypyridinoline levels
Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine).
Time frame: First day
Measuring spot urine calcium levels
Measuring urine calcium levels with spectrophotometric method (mg/dL).
Time frame: First day
Measuring urine creatinine levels
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Measuring urine creatinine levels with spectrophotometric method (mg/dL).
Time frame: First day
Measuring urine C-terminal telopeptides Type I collagen levels
Measuring urine C-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).
Time frame: First day
Measuring urine N-terminal telopeptides Type I collagen levels
Measuring urine N-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL).
Time frame: First day