High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274203
• Other study ID #: 10584-2/5-2023
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 10, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• children with SCD (HbSS, hemoglobin sickle beta zero (HbSß0) 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Bone Mineral Density
• Health Related Quality of Life
• Sickle Cell Disease
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D level	Serum 25(OH)D level change from baseline at 6 months	up to 6 months
Secondary	Bone mineral density (BMD)	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	up to 6 months
Secondary	Maximum handgrip strength (HGS)	Hand grip power using a handheld dynamometer.	up to 6 months
Secondary	Health related quality of life (HRQL)	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.	up to 6 months
Secondary	Serum concentrations of C reactive protein (CRP)	Serum concentrations of inflammatory marker (CRP) level change from baseline	up to 6 months
Secondary	Serum concentrations of Erythrocyte sedimentation rate (ESR)	Serum concentrations of inflammatory marker (ESR) level change from baseline	up to 6 months
Secondary	Safety reporting of any adverse events	e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhythmias, renal failure, coma	up to 6 months
Secondary	Safety measurements of serum Ca	serum Ca levels	at 3 and 6 months
Secondary	childhood health assessment	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.	up to 6 months
Secondary	Safety measurements of serum 25(OH)D levels	serum 25(OH)D levels	at 3 and 6 months