Bone Turnover Rate Disorder, Calcium Metabolism Disorders
Conditions
Keywords
Lansoprazole, Bone turnover, Gastroesophageal reflux
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTBlood and urine specimens
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.
Sponsors
Ataturk University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
• Patients diagnosed with gastroesophageal reflux or gastroesophageal reflux disease aged 16 to18 years.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring serum calcium levels | First day | Measuring serum calcium levels with spectrophotometric method (mg/dL). |
| Measuring serum alkaline phosphatase levels | First day | Measuring serum alkaline phosphatase levels with spectrophotometric method (U/L). |
| Measuring serum magnesium levels | First day | Measuring serum magnesium levels with spectrophotometric method (mg/dL). |
| Measuring serum osteocalcin levels | First day | Measuring serum osteocalcin levels with spectrophotometric method (mg/L). |
| Measuring serum parathyroid hormone levels | First day | Measuring serum parathyroid hormone levels with immunoassay method (pg/mL). |
| Measuring serum vitamin D levels | First day | Measuring serum vitamin D with immunoassay method (ng/mL). |
| Measuring urine deoxypyridinoline levels | First day | Measuring urine deoxypyridinoline levels with immunoassay method (nmol DPD/mmol creatinine). |
| Measuring spot urine calcium levels | First day | Measuring urine calcium levels with spectrophotometric method (mg/dL). |
| Measuring urine creatinine levels | First day | Measuring urine creatinine levels with spectrophotometric method (mg/dL). |
| Measuring urine C-terminal telopeptides Type I collagen levels | First day | Measuring urine C-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL). |
| Measuring urine N-terminal telopeptides Type I collagen levels | First day | Measuring urine N-terminal telopeptides Type I collagen levels with immunoassay method (ng/mL). |
Countries
Turkey (Türkiye)
Outcome results
None listed