drugset / Trial / NCT06964334

The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

NCT06964334

Phase 3 Not yet recruiting 70 enrolled Assiut University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Helicobacter pylori (H. pylori) is one of the most common chronic infections worldwide. The mode of transmission of H. pylori is through the fecal-oral or oral-oral routes. Chronic gastritis has been linked to helicobacter pylori (H. pylori) infection. Peptic ulcer disease, gastric adenocarcinoma, and gastric lymphoma are all linked to this condition . In Egypt, a high prevalence of H. pylori infections has been reported, ranging from 70% in the general population , 73% among school children , up to 88% in patients with chronic active HCV . In 2007, the American College of Gastroenterology estimated that the cure rate for H. pylori infections was 70-85 percent with the use of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole . children with H. pylori infection do not have severe digestive symptoms. pylori infection represents a key factor in the pathogenesis of duodenal ulcer and chronic gastritis in children. In addition, H. pylori infection has also been reported to have extra-digestive consequences . A recent comprehensive evaluation found that sequential and conventional triple treatment had a cure rate of 84% . The infected macrophage is unable to create enough 1,25-(OH)2D to control the synthesis of AMP cathelicidin when it is vitamin D deficient . vitamin D has a powerful systemic antibacterial impact by enhancing the activity of monocytes and macrophages. Most illnesses seem to benefit from a vitamin D-rich condition . Vitamin D-deficient subjects might be more prone to developing H. pylori infection .

Timeline

Start
2025-06-01
Primary completion
2026-06-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vitamin D Other / unclassified 4000 iu
Comparator Vitamin D Other / unclassified 5000 iu
Comparator Amoxicillin Other / unclassified 50 mg/kg
Comparator Clarithromycin Small molecule 15 mg/kg Oral
Comparator Lansoprazole Other / unclassified 1 mg/kg Oral