High Dose Vitamin D Supplementation in Children With Sickle Cell Disease (NCT06274203) | Clinical Trial Compass
CompletedNot Applicable
High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
Egypt75 participantsStarted 2023-05-03
Plain-language summary
Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.