High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

NCT06274203 | Completed

• 1 other identifier: 10584-2/5-2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Serum 25(OH)D level

  Serum 25(OH)D level change from baseline at 6 months

  up to 6 months

Secondary Outcomes (9)

• Bone mineral density (BMD)

  up to 6 months

• Maximum handgrip strength (HGS)

  up to 6 months

• Health related quality of life (HRQL)

  up to 6 months

• Serum concentrations of C reactive protein (CRP)

  up to 6 months

• Serum concentrations of Erythrocyte sedimentation rate (ESR)

  up to 6 months

Study Arms (1)

Oral vitamin D3

EXPERIMENTAL

Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU)

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Oral vitamin D3

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (1)

• Hanna D, Kamal DE, Fawzy HM, Abd Elkhalek R. Safety and efficacy of monthly high-dose vitamin D3 supplementation in children and adolescents with sickle cell disease. Eur J Pediatr. 2024 Aug;183(8):3347-3357. doi: 10.1007/s00431-024-05572-w. Epub 2024 May 14.

  PMID: 38743288 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric hematology and oncology

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 23, 2024
• Study Start: May 3, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 10, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

EG (1)