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Vitamin D for Sickle-cell Respiratory Complications

NCT01443728 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-09

Study results available
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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

Conditions

Interventions

DRUG

Experimental: Vitamin D3 100,000 IU

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

DRUG

Active Comparator: Vitamin D3 12,000 IU

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

Sponsors & Collaborators

  • Gary M Brittenham, MD

    lead OTHER

Principal Investigators

  • Gary Brittenham, MD · Columbia University

  • Margaret T. Lee, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-13
Primary Completion
2013-06-20
Completion
2015-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443728 on ClinicalTrials.gov