Helicobacter Pylori InfectionNCT05879237
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
A study testing Vitamin D3 and Helicobacter pylori triple therapy in people with Helicobacter Pylori Infection, run by Minia University.
Trial summary
To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vitamin D3 and Helicobacter pylori triple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
Read the detailed description
- 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
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vitamin D3, Helicobacter pylori triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called cholecalciferol
Vitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy
Helicobacter pylori triple therapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Vitamin D3; Drug: Helicobacter pylori triple therapy |
| Triple therapy only | Active comparator | Standard triple therapy of H pylori Receives: Drug: Helicobacter pylori triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
eradication of h pylori in children
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Shimaa Mohamed Yassin, Minia University
- Investigators
- samir M mounir, ass prof, Study director, Minia UniversityYosra M awad, lecturer, Study director, ain shams university .faculty of medicineshimaa M yassin, ass lect, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879237
- Sponsor's protocol ID
- 2021:42
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study role of vitamin D supplementation as an Adjuvant Therapy IN Treatment of Helicobacter Pylori in Children
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
- ClinicalTrials.gov ID
- NCT05879237
- Acronym / sponsor ID
- 2021:42
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
Detailed description
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
| Arm | Type | Receives |
|---|---|---|
| Triple therapy therapy and vitamin D3 | Active comparator | Drug: Vitamin D3, Drug: Helicobacter pylori triple therapyVitamin D3 ,1000 unit ,once daily, oral, for 1 month plus the standard triple therapy of H pylori (double antibiotics and proton pump inhibitor) |
| Triple therapy only | Active comparator | Drug: Helicobacter pylori triple therapyStandard triple therapy of H pylori |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolVitamin D3 ,1000 unit ,once daily, oral, for 1 month plus triple therapy | Drug | Triple therapy therapy and vitamin D3 |
| Helicobacter pylori triple therapyTriple 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 | Drug | Triple therapy only, Triple therapy therapy and vitamin D3 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes. study role of vitamin D supplementation as an Adjuvant Therapy IN Treatment of Helicobacter Pylori in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samir M mounir, ass prof study director
Minia University
Yosra M awad, lecturer study director
ain shams university .faculty of medicine
shimaa M yassin, ass lect principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Helicobacter pylori triple therapy in people with Helicobacter Pylori Infection, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gihan M bebars, proffesor (01001196768 ext. +2, Gihan.bebars@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.