Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children

Minia University

Status: Not yet enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Helicobacter pylori triple therapy; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05879237

2021:42

Details and patient eligibility

About

To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

Full description

o study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

our study include 2 patient groups:

1. st group included 100 child diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment and vitamin D as an adjuvant therapy .
2. nd group will also diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment only.

Helicobacter pylori treatment :

1. amoxcillin on 50 mg/kg/day for 2 weeks
2. clarithromycin 20mg/kg/day for 2 weeks
3. proton pump inhibitor 1mg/kg/day for 1month Vitamin d dose..1000unit /day for 1 month

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age:4-18 years children with symptomatic H pylori infection presenting with (epigastric pain, persistent vomiting and hematemesis)diagnosed by upper gastrodeudonoscopy , rapid urease test and histopathologic examination of gastric biopsies from antrum and body of the stomach.

Exclusion criteria

• Patient on vitamine D supplémentation
• Patient who has defect in vitamin D metabolism (chronic renal and hepatic patients, malabsorption syndromes)
• Patients who had received treatment of H.pylori previously .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Triple therapy therapy and vitamin D3

Active Comparator group

Description:

Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus the standard triple therapy of H pylori (double antibiotics and proton pump inhibitor)

Treatment:

Drug: Helicobacter pylori triple therapy

Drug: Vitamin D3

Triple therapy only

Active Comparator group

Description:

Standard triple therapy of H pylori

Treatment:

Drug: Helicobacter pylori triple therapy