Study of Vitamin D in Children With Sickle Cell Disease

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary M Brittenham, MD
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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