Does adding Vitamin D to standard antibiotic treatment help cure Helicobacter pylori infection in patients with indigestion?

Effectiveness of vitamin D as an add-on therapy on LOAD regime for eradication of Helicobacter pylori infection: A randomized controlled trial at Mayo Hospital Lahore

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000840381

Enrollment

Registered

2026-07-10

Start date

2024-08-30

Completion date

2025-02-26

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Helicobacter pylori infection remains highly prevalent in developing countries and increasing antibiotic resistance has reduced the success of conventional eradication therapies. This randomized controlled trial aimed to evaluate the effectiveness of vitamin D supplementation as an adjunct to the LOAD regimen (Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline) for eradication of Helicobacter pylori infection. A total of 88 biopsy-confirmed H. pylori-positive patients were randomly allocated into two groups: one receiving the LOAD regimen alone and the other receiving LOAD therapy plus vitamin D3 supplementation for four weeks. Eradication of infection was assessed through repeat endoscopic biopsy after treatment completion.

Interventions

Participants receive the LOAD regimen (Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline) for Helicobacter pylori eradication along with oral Vitamin D supplementation. Treatment details: Levofloxacin 250 mg oral tablet, once daily, Omeprazole 40 mg oral tablet, twice daily, Nitazoxanide 500 mg oral tablet, twice daily Doxycycline 100 mg oral tablet, once daily for 10 days In addition, participants receive once weekly oral Vitamin D (cholecalciferol) 5000IU supplementation for 4 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

• Dyspeptic patients diagnosed with helicobacter pylori gastritis with positive biopsy results (two samples taken from antrum and 2 from body if stomach). • serum Vitamin D level from 30ng/ml to 70ng/ml( involving optimal vitamin D group) and asymptomatic. • Written consent sign from participants

Exclusion criteria

• Pregnant ladies or lactating mothers • Patients who have been treated for helicobacter pylori eradication in past 1 month. • Patients who have used vitamin D or Proton pump inhibitors (PPI) in past 2 weeks. • A history of systemic inflammatory or autoimmune disorders, liver cirrhosis,Gastroesophageal Reflux Disease (GERD), irritable bowel syndrome (IBS), malignancy, renal failure, and bone pains. • Patients taken antibiotics for any other reasons in past 1 month

Outcome results