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NCT Number: NCT06964334

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

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 .

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

To assess the efficacy of adding vitamin D supplement as adjuvant therapy in eliminating helicobacter pylori infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lansoprazole

Drug

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

Amoxicillin

Drug

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

Clarithromycin

Drug

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

Vitamin D

Drug

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

Primary outcomes

  1. cure rate after treatment

    Time frame: 3 months

    compare cure rate between two groups

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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