a clinical trial to study the effect of metformin and its correlation with vitamin d levels in patients with pulmonary fibrosis

To evaluate the effect of add on Metformin and its correlation with serum vitamin D levels in patients of pulmonary fibrosis – A randomized, open label, proof of concept study - nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059325

Enrollment

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis

Interventions

Intervention1: standard therapy and Metformin: Metformin is a oral anti diabetic drug in biguanide class. Metformin 500 mg will be administered in oral formulation twice daily for 3 months (90 days) C

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 40 years 2.Patients of pulmonary fibrosis diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) guidelines by High-Resolution Computerized Tomography (HRCT) pattern, and/ or, if available, surgical lung biopsy pattern.

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to participate and will not provide informed consent. 2. Pregnant and lactating women 3. Patients with Diabetes 4. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN) 5. Bilirubin > 1.5 x ULN; 6. Airway obstruction (i.e., pre-bronchodilator FEV1/FVC 7. Patient likely to have lung transplantation during the study (being on transplantation list is acceptable for participation); 8. Myocardial infarction within 6 months; 9. Unstable angina within 1 month

Design outcomes

Primary

Measure	Time frame
1. Kerbs von den Lungen-6 (KL-6) 2. Transforming growth factor beta (TGF-beta) 3. Matrix metalloproteinase 1 4. Matrix metalloproteinase 7 5. Serum vitamin D levels 6. 6-minute walk test 7. Forced vital capacity (FVC).Timepoint: At the time of enrollment and at the end of 3 months (90 days)	—

Secondary

Measure	Time frame
1. Body weight 2. fasting blood sugar 3. HbA1c 4. Vitamin B12Timepoint: At the time of enrollment and at the end of 3 months (90 days)	—

Countries

India

Contacts

Public ContactDr Shivom Pratap

All India Institute of Medical Sciences

dsarya16@gmail.com01126594266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026