Sickle Cell DiseaseNCT06274203
High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
A study testing Vitamin D3 in people with Sickle Cell Disease and Vitamin D Deficiency, run by Zagazig University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Vitamin D Deficiency, Health Related Quality of Life
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2023to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents
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
- Being tested
- Vitamin D3
- Medical subject headings
- Anemia, Sickle Cell, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral vitamin D3 | Experimental | Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU) Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D level
Serum 25(OH)D level change from baseline at 6 months
Measured: up to 6 months
Secondary outcomes (9)
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
Measured: up to 6 months
Maximum handgrip strength (HGS)
Hand grip power using a handheld dynamometer.
Measured: up to 6 months
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.
Measured: up to 6 months
Serum concentrations of C reactive protein (CRP)
Serum concentrations of inflammatory marker (CRP) level change from baseline
Measured: up to 6 months
Serum concentrations of Erythrocyte sedimentation rate (ESR)
Serum concentrations of inflammatory marker (ESR) level change from baseline
Measured: up to 6 months
Safety reporting of any adverse events
e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhythmias, renal failure, coma
Measured: up to 6 months
Safety measurements of serum Ca
serum Ca levels
Measured: at 3 and 6 months
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.
Measured: up to 6 months
Safety measurements of serum 25(OH)D levels
serum 25(OH)D levels
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 May 2023
- Primary completion30 Jan 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Diana Hanna Abdelmalek Hanna, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274203
- Sponsor's protocol ID
- 10584-2/5-2023
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38743288
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents
- ClinicalTrials.gov ID
- NCT06274203
- Acronym / sponsor ID
- 10584-2/5-2023
- Conditions
- Sickle Cell Disease, Vitamin D Deficiency, Health Related Quality of Life, Hand Grip Strength, Bone Mineral Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral vitamin D3 | Experimental | Drug: Vitamin D3Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Subjects 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. | Drug | Oral vitamin D3 |
Primary outcome
Serum 25(OH)D level
Time frame: up to 6 months
Serum 25(OH)D level change from baseline at 6 months
9 secondary outcomes
Bone mineral density (BMD)
Time frame: up to 6 months
Maximum handgrip strength (HGS)
Time frame: up to 6 months
Health related quality of life (HRQL)
Time frame: up to 6 months
Serum concentrations of C reactive protein (CRP)
Time frame: up to 6 months
Serum concentrations of Erythrocyte sedimentation rate (ESR)
Time frame: up to 6 months
Safety reporting of any adverse events
Time frame: up to 6 months
Safety measurements of serum Ca
Time frame: at 3 and 6 months
childhood health assessment
Time frame: up to 6 months
Safety measurements of serum 25(OH)D levels
Time frame: at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 38743288Hanna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Sickle Cell Disease and Vitamin D Deficiency, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D level (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.