Status:
COMPLETED
Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Mahidol University
Conditions:
Thalassemia
Iron Overload
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
Genetic disorders, such as thalassemia, can lead to iron overload and severe adverse health outcomes. In iron-loading thalassemia, iron overload is due to increased iron absorption. Iron accumulates i...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Documented diagnosis of thalassemia minor or intermedia (β-thalassemia with or without α-globin gene mutations, Hb E/β-thalassemia with or without α-globin gene mutations, or α-thalassemia Hb H disease) based on Hb electrophoresis/HPLC and/or DNA analysis from the subject's medical record.
- Hemoglobin (Hb): 7.0-13.5 g/dL for males; 7.0-12.0 for females
- Serum ferritin (SF): 300-800 ug/L for males; 200-800 ug/L for females
- Not having had a blood transfusion within 6 months prior to the study start
- Age 18-49 y, not pregnant or lactating
- Body weight \<75 kg and body mass index (BMI) between 17 and 25 kg/m2
- No acute illness/infection (self-reported)
- No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported)
- No scheduled phlebotomy or blood transfusion during the study period
- The last phlebotomy will be at least 4 weeks prior to first study visit
- No intake of iron chelators 4 weeks prior to first study visit and throughout the study period
- No use of medications affecting iron absorption or metabolism during the study
- No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study
- No participation in any other clinical study within the last 30 days and during the study
- Expected to comply with study protocol
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05326503
Start Date
June 1 2022
End Date
September 11 2023
Last Update
March 5 2025
Active Locations (1)
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1
Mahidol University
Salaya, Thailand