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

NCT05879237 | Unknown DMC

• 1 other identifier: 2021:42
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

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

  eradication of h pylori in children

  Six month

Study Arms (2)

Triple therapy therapy and vitamin D3

ACTIVE COMPARATOR

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; Drug: Helicobacter pylori triple therapy

Triple therapy only

ACTIVE COMPARATOR

Standard triple therapy of H pylori

Drug: Helicobacter pylori triple therapy

Interventions

Vitamin D3 DRUG

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

Also known as: cholecalciferol

Triple therapy therapy and vitamin D3

Helicobacter pylori triple therapy 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; Triple therapy therapy and vitamin D3

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Minia University: lead
• Ain Shams University: collaborator

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• samir M mounir, ass prof

  Minia University, faculty of medicine

  STUDY DIRECTOR

• Yosra M awad, lecturer

  ain shams university .faculty of medicine

  STUDY DIRECTOR

• shimaa M yassin, ass lect

  Minia University, faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gihan M bebars, proffesor

CONTACT

01001196768; Gihan.bebars@mu.edu.eg

Ahmed M hamdy, proffesor

CONTACT

01019334332; a-hamdy13@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

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

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 month
• 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