Daily Vitamin D for Sickle-cell Respiratory Complications

ClinicalTrials.gov ID: NCT04170348

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04170348
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Columbia University; Other
Enrollment: 58 participants

Conditions and interventions

Conditions

Interventions

Daily oral vitamin D3, 3,333 IU Drug
Monthly oral vitamin D3, 100,000 IU Drug
Placebo oral tablet Drug

Drug

Eligibility (public fields only)

Age range: 3 Years to 20 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 15, 2020 (Actual)
Primary completion: Jun 18, 2024 (Actual)
Completion: Jun 18, 2024 (Actual)
Last update posted: Sep 24, 2025

2020 – 2024

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Columbia University Medical Center	New York	New York	10032	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04170348, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 24, 2025 · Synced Nov 15, 2026