Daily Vitamin D for Sickle-cell Respiratory Complications

• Status: Recruiting
• Trial end date: 2024-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease.

This study is funded by the FDA Office of Orphan Products Development (OOPD).

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

Details

• Lead Sponsor: Gary M Brittenham, MD
• Collaborator: FDA Office of Orphan Products Development
• Treatments: Cholecalciferol; Ergocalciferols; Trientine; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Diagnosis of sickle cell disease (Hb SS, Hb SC, Hb S-Beta-thalassemia)

2. Age 3-20 years old

Exclusion Criteria:

1. Patient unwilling or unable to provide written informed consent (and assent, if applicable)

2. Patient unable or unwilling to comply with requirements of the clinical trial

3. Participation in another clinical trial

4. Current diagnosis of rickets

5. History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia

6. Current use of corticosteroids, excluding inhaled steroids

7. Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)

8. Therapy with thiazide diuretics or lithium carbonate

9. Known liver or renal disease

10. Patients taking medications for pulmonary complications of sickle cell disease not on a stable dose of medications, as defined by a change in medications or doses within the three months prior to study entry

11. Patients on chronic red blood cell transfusion therapy