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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral vitamin D3 | Experimental | Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25(OH)D level | Serum 25(OH)D level change from baseline at 6 months | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum handgrip strength (HGS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig university | Zagazig | Sharqia Province | 44519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38743288 | Derived | 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. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
Hand grip power using a handheld dynamometer.
| 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. | up to 6 months |
| Serum concentrations of C reactive protein (CRP) | Serum concentrations of inflammatory marker (CRP) level change from baseline | up to 6 months |
| Serum concentrations of Erythrocyte sedimentation rate (ESR) | Serum concentrations of inflammatory marker (ESR) level change from baseline | 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 | up to 6 months |
| Safety measurements of serum Ca | serum Ca levels | 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. | up to 6 months |
| Safety measurements of serum 25(OH)D levels | serum 25(OH)D levels | at 3 and 6 months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |