High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

Not Applicable

Completed

• Conditions: Hand Grip Strength; Bone Mineral Density; Sickle Cell Disease; Vitamin D Deficiency; Health Related Quality of Life
• Interventions: Drug: Vitamin D3

• Registration Number: NCT06274203
• Lead Sponsor: Zagazig University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-03
• Primary Completion: 2024-01-30
• Status Verified: 2024-02
• Study Completion: 2024-02-10
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral vitamin D3	Vitamin D3	Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU)

Primary Outcome Measures

Name	Time	Method
Serum 25(OH)D level	up to 6 months	Serum 25(OH)D level change from baseline at 6 months

Secondary Outcome Measures

Name	Time	Method
Safety measurements of serum Ca	at 3 and 6 months	serum Ca levels
childhood health assessment	up to 6 months	Assessed by childhood health assessment questionnaire (CHAQ), There are four potential responses to each question: "without any difficulty" (score 0); "with some difficulty" (score 1); "with much difficulty" (score 2); and "unable to do" (score 3). A summary score known as CHAQ-DI/, which varies from 0 to 3, is calculated by averaging the highest score in each domain. For a CHAQ-DI score to be considered minimally clinically significant, it must be ≥ 0.75.
Bone mineral density (BMD)	up to 6 months	BMD was evaluated at the posterior-anterior spine, Z-scores were used to interpret the results, with Z-scores less than -2 standard deviation (SD) being regarded as abnormal
Maximum handgrip strength (HGS)	up to 6 months	Hand grip power using a handheld dynamometer.
Serum concentrations of C reactive protein (CRP)	up to 6 months	Serum concentrations of inflammatory marker (CRP) level change from baseline
Serum concentrations of Erythrocyte sedimentation rate (ESR)	up to 6 months	Serum concentrations of inflammatory marker (ESR) level change from baseline
Health related quality of life (HRQL)	up to 6 months	Health related quality of life (HRQL) assessed by HRQL questionnaires, The questionnaire was divided into eight subscales: physical function, role limitations resulting from physical health, bodily pain, general health perception, vitality, social function, role limitations resulting from emotional problems, and mental health. For each subscale: higher score indicated good health and ranged from 0 to 100.
Safety reporting of any adverse events	up to 6 months	e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhythmias, renal failure, coma
Safety measurements of serum 25(OH)D levels	at 3 and 6 months	serum 25(OH)D levels

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt