NCT06964334

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

To assess the efficacy of adding vitamin D supplement as adjuvant therapy in eliminating helicobacter pylori infection.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Lansoprazole	oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day
DRUG	amoxicillin	amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day
DRUG	clarithromycin	oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day
DRUG	vitamin D	vitamin D therapy of 4000-5000 units daily in patients over 12 months old.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-05-09
• Last updated: 2025-05-09

Regulatory

• FDA-regulated drug study