Phase 2
Completed N=4
Study of Vitamin D in Children With Sickle Cell Disease
Source: ClinicalTrials.gov NCT01276587 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Serum 25-hydroxyvitamin D Concentration — 28.5; 36.5; 41.0; 41.75 ng/mL
Summary
This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation, 100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the threshold for toxicity (150 ng/mL) in children with sickle cell disease. Information from this study will be crucial before we perform a larger clinical trial to determine the effects of vitamin D in reducing respiratory complications in patients with sickle cell disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum 25-hydroxyvitamin D Concentration |
28.5; 36.5; 41.0; 41.75; 40.75; 42.5 | — |
Eligibility Criteria
Inclusion Criteria
- patients with sickle cell disease
- 3 to 20 years old
- pregnant females with sickle cell disease are eligible
Exclusion Criteria
- no informed consent or assent
- unable or unwilling to comply with requirements of the clinical trial
- participation in another clinical trial
- history of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, such as primary hyperparathyroidism, malignancy, familial hypocalciuric hypercalcemia, William's syndrome and other rare causes
- therapy with thiazide diuretics or lithium carbonate
- known renal or liver disease
- known malabsorption syndrome and inflammatory bowel disease
- chronic use of corticosteroids, excluding inhaled steroids
- current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)
- current intake of vitamin D and calcium supplements
- initiation of hydroxyurea or iron chelation therapy within the past 3 months
- serum 25hydroxyvitamin D >60 ng/mL
Data sourced from ClinicalTrials.gov (NCT01276587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.