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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06274203
Eligibility Criteria:
Inclusion Criteria:
* children with SCD (HbSS, hemoglobin sickle beta zero (HbSβ0) thalassemia genotype), aged ≤ 18 years old, male or female study participants who were at a steady state (≥ one month from blood transfusion and ≥ 14 days from any acute sickle complication as hospitalization for Vaso occlusive crisis (VOC) or acute chest syndrome (ACS)), stable Hb level near their usual baseline and stable dose of Hydroxyurea (HÚ) mg/kg for at least 90 days prior to enrollment.
* A control group of 42 healthy age and sex-matching children
Exclusion Criteria:
* SCD patients who are on chronic blood transfusion therapy
* Comorbid chronic conditions
* Use of medications known to interfere with calcium or vitamin D absorption or metabolism
* Known hypercalcemia or vitamin D hypersensitivity
* Use of vitamin D therapy to treat vitamin D deficiency or rickets
* Urolithiasis, liver or renal impairment, and malabsorption disorders.
* Obese children with body mass index (BMI) \> 85th percentile for age and sex
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06274203
Study Brief:
Protocol Section:
NCT06274203