CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Daily oral vitamin D3, 3,333 IU +2 moredrug
Likely dose
Daily oral vitamin D3, 3,333 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/NCT04170348
NCT04170348Phase 2Completed
CompareCT.gov

Daily Vitamin D for Sickle-cell Respiratory Complications

Columbia University·interventional·Posted Nov 20, 2019·Updated Sep 24, 2025

In Brief

A Phase 2 clinical trial evaluating Daily oral vitamin D3, 3,333 IU, Monthly oral vitamin D3, 100,000 IU, and 1 other intervention for Sickle Cell Disease and 11 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease, Anemia, Sickle Cell, Anemia, Hemolytic, Congenital, Respiratory Tract Diseases, Respiration Disorders, Acute Chest Syndrome, Lung Diseases, Asthma, Respiratory Tract Infections, Nutrition Disorders, Deficiency Diseases Vitamin, Vitamin D Deficiency
CountriesUnited States
CollaboratorsFDA Office of Orphan Products Development

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 20, 2019
Enrollment StartSep 15, 2020
Primary CompletionJun 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.6 years ago

Interventions

Daily oral vitamin D3, 3,333 IUdrug

Oral vitamin D3, 3,333 IU, will be administered daily.

Monthly oral vitamin D3, 100,000 IUdrug

Oral vitamin D3, 100,000 IU, will be administered monthly.

Placebo oral tabletdrug

Participants randomized to receive once monthly oral bolus of vitamin D3, will receive placebo on all other days of the month.