CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Experimental: Vitamin D3 100,000 IU +1 moredrug
Likely dose
Experimental: Vitamin D3 100,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01443728
NCT01443728Phase 2Completed

Vitamin D for Sickle-cell Respiratory Complications

Gary M Brittenham, MD·interventional·Posted Sep 30, 2011·Updated Aug 9, 2024

In Brief

A Phase 2 clinical trial evaluating Experimental: Vitamin D3 100,000 IU and Active Comparator: Vitamin D3 12,000 IU for Sickle Cell Disease and 4 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed Summary

This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month. Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2011
Enrollment StartDec 13, 2011
Primary CompletionJun 20, 2013
Study CompletionFeb 15, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.8 years ago

Interventions

Experimental: Vitamin D3 100,000 IUdrug

Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month

Active Comparator: Vitamin D3 12,000 IUdrug

Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month