NCT04170348CompletedPhase 2
Daily Vitamin D for Sickle-cell Respiratory Complications
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 1 Oct 2019
- Start date
- 15 Sept 2020
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- Columbia University
- Diseases
- Sickle cell disease, Asthma
- NCT number
- NCT04170348
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 58
- From 15 Sept 2020 to the primary completion date, 18 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of corticosteroids, excluding inhaled steroids
- Therapy with thiazide diuretics or lithium carbonate
- 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
- Patients on chronic red blood cell transfusion therapy
Other illness
- History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia
- Known liver or renal disease
Other
- Patient unwilling or unable to provide written informed consent (and assent, if applicable)
- Patient unable or unwilling to comply with requirements of the clinical trial
- Participation in another clinical trial
- Current diagnosis of rickets
- Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)
Who the study is looking for
- Diagnosis of sickle cell disease (Hb SS, Hb SC, Hb S-Beta-thalassemia)
- Age 3-20 years old
Age in the registry: 3 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.