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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-10

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.

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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:

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

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triple therapy therapy and vitamin D3

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy

Helicobacter pylori triple therapy

Intervention Type DRUG

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

Triple therapy only

Standard triple therapy of H pylori

Group Type ACTIVE_COMPARATOR

Helicobacter pylori triple therapy

Intervention Type DRUG

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

Interventions

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Vitamin D3

Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy

Intervention Type DRUG

Helicobacter pylori triple therapy

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

Intervention Type DRUG

Other Intervention Names

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cholecalciferol

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 .

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes