Clinical trial NCT06274203: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
Official title: Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Vitamin D Deficiency
Health Related Quality of Life
Hand Grip Strength
Bone Mineral Density
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-02-23
Enrollment: 75
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Serum 25(OH)D level
timeFrame: up to 6 months
Secondary outcomes:
measure: Bone mineral density (BMD)
timeFrame: up to 6 months
measure: Maximum handgrip strength (HGS)
timeFrame: up to 6 months
measure: Health related quality of life (HRQL)
timeFrame: up to 6 months
measure: Serum concentrations of C reactive protein (CRP)
timeFrame: up to 6 months
measure: Serum concentrations of Erythrocyte sedimentation rate (ESR)
timeFrame: up to 6 months
measure: Safety reporting of any adverse events
timeFrame: up to 6 months
measure: Safety measurements of serum Ca
timeFrame: at 3 and 6 months
measure: childhood health assessment
timeFrame: up to 6 months
measure: Safety measurements of serum 25(OH)D levels
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
References: