Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Serum 25(OH)D level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral vitamin D3
Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU)
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Serum 25(OH)D level
时间窗: up to 6 months
Serum 25(OH)D level change from baseline at 6 months
次要结局
- Safety measurements of serum Ca(at 3 and 6 months)
- childhood health assessment(up to 6 months)
- Serum concentrations of Erythrocyte sedimentation rate (ESR)(up to 6 months)
- Bone mineral density (BMD)(up to 6 months)
- Maximum handgrip strength (HGS)(up to 6 months)
- Serum concentrations of C reactive protein (CRP)(up to 6 months)
- Health related quality of life (HRQL)(up to 6 months)
- Safety reporting of any adverse events(up to 6 months)
- Safety measurements of serum 25(OH)D levels(at 3 and 6 months)
研究者
Diana Hanna Abdelmalek Hanna
Lecturer of pediatric hematology and oncology
Zagazig University