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临床试验/NCT05879237
NCT05879237尚未招募不适用

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

Minia University0 个研究点目标入组 200 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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 .

研究组 & 干预措施

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)

干预措施: Vitamin D3 (Drug)

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)

干预措施: Helicobacter pylori triple therapy (Drug)

Triple therapy only

Active Comparator

Standard triple therapy of H pylori

干预措施: Helicobacter pylori triple therapy (Drug)

结局指标

主要结局

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

时间窗: Six month

eradication of h pylori in children

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Mohamed Yassin

Doctor

Minia University

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