NCT06274203Completed
High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents
Source: ClinicalTrials.gov · Last updated 23 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 13 Feb 2024
- Start date
- 3 May 2023
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Zagazig University
- Diseases
- Sickle cell disease
- NCT number
- NCT06274203
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 3 May 2023 to the primary completion date, 30 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- SCD patients who are on chronic blood transfusion therapy
- Use of vitamin D therapy to treat vitamin D deficiency or rickets
Other illness
- Comorbid chronic conditions
- Known hypercalcemia or vitamin D hypersensitivity
- Urolithiasis, liver or renal impairment, and malabsorption disorders.
Lab values
- Use of medications known to interfere with calcium or vitamin D absorption or metabolism
Age
- Obese children with body mass index (BMI) \> 85th percentile for age and sex
Who the study is looking for
- 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
Age in the registry: - to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zagazig University Coordinator of this site? Confirm its status | Zagazig | Egypt | Unknown status |
Related publications
- Safety and efficacy of monthly high-dose vitamin D3 supplementation in children and adolescents with sickle cell disease.Eur J Pediatr · 2024 · PMID 38743288
This page is information, not medical advice. Discuss any trial with your doctor.