The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection
NCT ID: NCT06964334
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2025-06-01
2026-08-01
Brief Summary
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Chronic gastritis has been linked to helicobacter pylori (H. pylori) infection. Peptic ulcer disease, gastric adenocarcinoma, and gastric lymphoma are all linked to this condition .
In Egypt, a high prevalence of H. pylori infections has been reported, ranging from 70% in the general population , 73% among school children , up to 88% in patients with chronic active HCV .
In 2007, the American College of Gastroenterology estimated that the cure rate for H. pylori infections was 70-85 percent with the use of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole .
children with H. pylori infection do not have severe digestive symptoms. pylori infection represents a key factor in the pathogenesis of duodenal ulcer and chronic gastritis in children. In addition, H. pylori infection has also been reported to have extra-digestive consequences .
A recent comprehensive evaluation found that sequential and conventional triple treatment had a cure rate of 84% .
The infected macrophage is unable to create enough 1,25-(OH)2D to control the synthesis of AMP cathelicidin when it is vitamin D deficient .
vitamin D has a powerful systemic antibacterial impact by enhancing the activity of monocytes and macrophages. Most illnesses seem to benefit from a vitamin D-rich condition .
Vitamin D-deficient subjects might be more prone to developing H. pylori infection .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and vitamin D supplement.
Lansoprazole
oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day
amoxicillin
amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day
clarithromycin
oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day
vitamin D
vitamin D therapy of 4000-5000 units daily in patients over 12 months old.
Group B
include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and without vit D supplement.
Lansoprazole
oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day
amoxicillin
amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day
clarithromycin
oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day
Interventions
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Lansoprazole
oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day
amoxicillin
amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day
clarithromycin
oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day
vitamin D
vitamin D therapy of 4000-5000 units daily in patients over 12 months old.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3\. History of systemic inflammatory or autoimmune disorders, gastric surgery, renal failure, liver cirrhosis and malignancies 4. Abnormal birth history such as premature birth and asphyxia or with severe disease history, such as genetic metabolic disease, congenital dysplasia, feeding difficulties, severe malnutrition, repeated respiratory diseases.
1 Year
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Samy Abdelsamie Sayed
residant doctor
Other Identifiers
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vit D supplement h.pylori
Identifier Type: -
Identifier Source: org_study_id
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