MedTrace Logo

Study of Vitamin D in Children With Sickle Cell Disease

NCT01276587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-04-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Vitamin D3

Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease

Sponsors & Collaborators

  • Gary M Brittenham, MD

    lead OTHER

Principal Investigators

  • Margaret T Lee, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

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 NCT01276587 on ClinicalTrials.gov