MedTrace Logo

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

NCT06964334 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-09

No results posted yet for this study

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 .

Conditions

  • Helicobacter Pylori Infection

Interventions

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-06-01
Completion
2026-08-01
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964334 on ClinicalTrials.gov