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

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

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

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Helicobacter pylori triple therapy


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple therapy therapy and vitamin D3<br>Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus the standard triple therapy of H pylori (double antibiotics and proton pump inhibitor) | Drug: Vitamin D3<br>* Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy<br>* Other names: cholecalciferol;Drug: Helicobacter pylori triple therapy<br>* Triple therapy which is: amoxcillin on 50 mg/kg/day for 2 weeks, Clarithromycin 20mg/kg/day for 2 weeks and proton pump inhibitor 3.ppi 1mg/kg/day for 1month<br>|
| Active Comparator: Triple therapy only<br>Standard triple therapy of H pylori | Drug: Helicobacter pylori triple therapy<br>* Triple therapy which is: amoxcillin on 50 mg/kg/day for 2 weeks, Clarithromycin 20mg/kg/day for 2 weeks and proton pump inhibitor 3.ppi 1mg/kg/day for 1month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children | eradication of h pylori in children | Six month |