Effect of omeprazole or resveratrol on iron status in thalassemia

Adjunct omeprazole or resveratrol in non-transfusion dependent thalassemia patients with secondary hemochromatosis: a randomized, double-blind, placebo-controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73258526

Enrollment

Registered

2025-01-08

Start date

2025-02-10

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

A decrease in serum iron levels in non-transfusion-dependent thalassemia patients Haematological Disorders

Interventions

The study will be conducted in non-transfusion-dependent thalassemia patients at the Out-patient department numbers 9 or 23 in Maharaj Nakorn Chiang Mai Hospital, Division of Hematology, Department of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 20-65 years old 2. Non-transfusion dependent thalassemia [alpha or beta] diagnosis by HPLC, PCR or gene mutation 3. Hemochromatosis with serum ferritin 300-1000 ng/mL or > 1000 ng/mL with a maximum iron chelator (DFP at 75 mg/kg/day or DFX at 20 mg/kg/day) 4. Concurrent iron chelators without changing dose during 3 months before enrollment and no tendency to adjust the dose of iron chelators between study 5. Inform consent

Exclusion criteria

Exclusion criteria: Not meeting the participant inclusion criteria

Design outcomes

Primary

Measure	Time frame
Changes in serum ferritin measured using an automated Biochemical Analyzer (immuno-chemiluminescence) at baseline, 3 and 6 months	—

Secondary

Measure	Time frame
The following secondary outcome measures are assessed at baseline, 3 and 6 months unless stated: 1. A CBC measured using an automated cell counter 2. Hemoglobin typing measured using cationic-exchange HPLC/DAD at baseline and 6 months. 3. Blood urea nitrogen measured using an automated biochemical analyzer 4. Creatinine measured using an automated biochemical analyzer 5. Electrolytes measured using an automated biochemical analyzer (ion selective method) 6. Aspartate aminotransferase measured using an automated biochemical analyzer (colorimetry) 7. Alanine aminotransferase measured using an automated biochemical analyzer (colorimetry) 8. Alkaline phosphatase measured using an automated biochemical analyzer (colorimetry) 9. Serum iron measured using an automated biochemical analyzer (ferrozine colorimetry) 10. Total iron-binding capacity measured using an automated biochemical analyzer (ferrozine colorimetry) 11. Labile plasma iron measured using Rhodamine B fluorochrome/spectrofluorometry 12. Non-transferrin bound iron measured using NTA/fluorescence chelator beads/flow cytometry a 13. Hepcidin measured using a sandwich enzyme-linked immunoassay 14. Erythroferrone measured using a sandwich enzyme-linked immunoassay 15. Vitamin B12 measured using reversed-phase HPLC/DAD 16. Vitamin D3 measured using a competitive enzyme-linked immunoassay	—

Measure

Time frame

The following secondary outcome measures are assessed at baseline, 3 and 6 months unless stated: 1. A CBC measured using an automated cell counter 2. Hemoglobin typing measured using cationic-exchange HPLC/DAD at baseline and 6 months. 3. Blood urea nitrogen measured using an automated biochemical analyzer 4. Creatinine measured using an automated biochemical analyzer 5. Electrolytes measured using an automated biochemical analyzer (ion selective method) 6. Aspartate aminotransferase measured using an automated biochemical analyzer (colorimetry) 7. Alanine aminotransferase measured using an automated biochemical analyzer (colorimetry) 8. Alkaline phosphatase measured using an automated biochemical analyzer (colorimetry) 9. Serum iron measured using an automated biochemical analyzer (ferrozine colorimetry) 10. Total iron-binding capacity measured using an automated biochemical analyzer (ferrozine colorimetry) 11. Labile plasma iron measured using Rhodamine B fluorochrome/spectrofluorometry 12. Non-transferrin bound iron measured using NTA/fluorescence chelator beads/flow cytometry a 13. Hepcidin measured using a sandwich enzyme-linked immunoassay 14. Erythroferrone measured using a sandwich enzyme-linked immunoassay 15. Vitamin B12 measured using reversed-phase HPLC/DAD 16. Vitamin D3 measured using a competitive enzyme-linked immunoassay

—

Countries

Thailand

Contacts

Public ContactThanapong Chopetgool

chopetgoolden@gmail.com+66 930748844

Outcome results

None listed

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