NCT06274203

High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sickle Cell Disease
• Vitamin D Deficiency
• Health Related Quality of Life
• Hand Grip Strength
• Bone Mineral Density

Interventions

Type	Name	Description
DRUG	Vitamin D3	Subjects within SCD as well as healthy controls, received monthly oral vitamin D3 dose, for 6 months, according to the baseline status of vitamin D as follows: sufficient (\>30 ng/mL): 100,000 IU, insufficient (20-29.9 ng/mL): 150,000 IU, and deficient (\<20 ng/mL): 200,000 IU.

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-01-30
• Completion: 2024-02-10
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: Egypt