Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT05326503
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05326503
Study Brief:
Protocol Section:
NCT05326503