Skip to main content
OpenTrials
Completed

NCT Number: NCT06274203

High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Avitaminosis Bone Mineral Density Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Genetic Diseases, Inborn Hand Grip Strength Health Related Quality of Life Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Serum 25(OH)D level

    Time frame: up to 6 months

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

Secondary outcomes

  1. Bone mineral density (BMD)

    Time frame: 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

  2. Maximum handgrip strength (HGS)

    Time frame: up to 6 months

    Hand grip power using a handheld dynamometer.

  3. Health related quality of life (HRQL)

    Time frame: 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.

  4. Serum concentrations of C reactive protein (CRP)

    Time frame: up to 6 months

    Serum concentrations of inflammatory marker (CRP) level change from baseline

  5. Serum concentrations of Erythrocyte sedimentation rate (ESR)

    Time frame: up to 6 months

    Serum concentrations of inflammatory marker (ESR) level change from baseline

  6. Safety reporting of any adverse events

    Time frame: up to 6 months

    e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhythmias, renal failure, coma

  7. Safety measurements of serum Ca

    Time frame: at 3 and 6 months

    serum Ca levels

  8. childhood health assessment

    Time frame: 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.

  9. Safety measurements of serum 25(OH)D levels

    Time frame: at 3 and 6 months

    serum 25(OH)D levels

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.