The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

NCT06964334 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: vit D supplement h.pylori
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Helicobacter pylori (H. pylori) is one of the most common chronic infections worldwide. The mode of transmission of H. pylori is through the fecal-oral or oral-oral routes. 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 .

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• cure rate after treatment

  compare cure rate between two groups

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and vitamin D supplement.

Drug: Lansoprazole; Drug: amoxicillin; Drug: clarithromycin; Drug: vitamin D

Group B

ACTIVE COMPARATOR

include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and without vit D supplement.

Drug: Lansoprazole; Drug: amoxicillin; Drug: clarithromycin

Interventions

Lansoprazole DRUG

oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day

Group A; Group B

amoxicillin DRUG

amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day

Group A; Group B

clarithromycin DRUG

oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day

Group A; Group B

vitamin D DRUG

vitamin D therapy of 4000-5000 units daily in patients over 12 months old.

Group A

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between 1 to 16 years old who present with helicobacter pylori infection diagnosed by positive stool antigen test for helicobacter pylori infection presented with weight loss, abdominal pain, or failure to surive symptoms for at least 1 month.

You may not qualify if:

• \- 1. Known hypersensitivity to PPIS or antibiotics. 2. Patients who have previously received helicobacter pylori eradication treatment, corticosteroids/immunosuppressive treatment and acid suppressive treatment in the prior 2 months.
• \. 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Lansoprazole; Amoxicillin; Clarithromycin; Vitamin D

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05