CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Vitamin D3drug
Likely dose
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/NCT01276587
NCT01276587Phase 2Completed
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Pilot Study of Vitamin D Therapy to Prevent Respiratory Complications in Children With Sickle Cell Disease

Gary M Brittenham, MD·interventional·Posted Jan 13, 2011·Updated Apr 12, 2023

In Brief

A Phase 2 clinical trial evaluating Vitamin D3 for Sickle Cell Disease. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.5 years ago

Interventions

Vitamin D3drug

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