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

Sponsor

Minia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05879237

Collaborator

Ain Shams University (Other)

200

Enrollment

Arms

6.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vitamin D3 Drug: Helicobacter pylori triple therapy	N/A

Detailed 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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Drug: Vitamin D3 Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy Other Names: cholecalciferol 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
Active Comparator: Triple therapy only Standard triple therapy of H pylori	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

Arm

Intervention/Treatment

Active Comparator: 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)

Drug: Vitamin D3

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

Other Names:

cholecalciferol

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

Active Comparator: Triple therapy only

Standard triple therapy of H pylori

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

Outcome Measures

Primary Outcome Measures

Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children [Six month]
eradication of h pylori in children

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Minia University
Ain Shams University

Investigators

Study Director: samir M mounir, ass prof, minia university.faculty of medicine
Study Director: Yosra M awad, lecturer, ain shams university .faculty of medicine
Principal Investigator: shimaa M yassin, ass lect, minia university.faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shimaa Mohamed Yassin, Doctor, Minia University

ClinicalTrials.gov Identifier:

NCT05879237

Other Study ID Numbers:

2021:42

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vitamin D

Cholecalciferol

Study Results

No Results Posted as of May 30, 2023