Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04814316
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2021-03-22
Brief Title:
Effects of Lansoprazole on Bone Turnover Markers
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
Evaluation of the Effects of Lansoprazole Usage on Bone Turnover Markers in Children With Gastroesophageal Reflux or Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientshealthy volunteers andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None