Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
May 18, 2023 updated by: Shimaa Mohamed Yassin, Minia University
To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gihan M bebars, proffesor
- Phone Number: +2 01001196768
- Email: Gihan.bebars@mu.edu.eg
Study Contact Backup
- Name: Ahmed M hamdy, proffesor
- Phone Number: +2 01019334332
- Email: a-hamdy13@med.asu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy
Other Names:
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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
Time Frame: Six month
|
eradication of h pylori in children
|
Six month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 10, 2023
Study Registration Dates
First Submitted
May 18, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021:42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
study role of vitamin D supplementation as an Adjuvant Therapy IN Treatment of Helicobacter Pylori in Children
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
study role of vitamin D supplementation as an Adjuvant Therapy IN Treatment of Helicobacter Pylori in Children revised by dr yosra m awad
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.