drugset / Trial / NCT06274203
High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-03
- Primary completion
- 2024-01-30
- Completion
- 2024-02-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 100000 iu | Oral |
| Subject | Cholecalciferol | Other / unclassified | 150000 iu | Oral |
| Subject | Cholecalciferol | Other / unclassified | 200000 iu | Oral |