NCT04170348 (ViDAS-2) is a Phase 2 clinical trial of Daily oral vitamin D3, 3,333 IU in Sickle Cell Disease, sponsored by Columbia University.

Who is sponsoring NCT04170348?

NCT04170348 is sponsored by Columbia University.

What drugs are being tested in NCT04170348?

Interventions in NCT04170348: Daily oral vitamin D3, 3,333 IU, Monthly oral vitamin D3, 100,000 IU, Placebo oral tablet.

What condition does NCT04170348 study?

NCT04170348 studies Sickle 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.

Is NCT04170348 still recruiting?

NCT04170348 is currently completed. Last updated 24 September 2025.

Are results published for NCT04170348?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-24 · How we verify

NCT04170348: ViDAS-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Daily Vitamin D for Sickle-cell Respiratory Complications

Completed Phase 2 Results posted Last updated 24 September 2025

What this trial tests

Phase 2 trial testing Daily oral vitamin D3, 3,333 IU in Sickle Cell Disease in 58 participants. Completed in 18 June 2024.

Timeline

15 September 2020

Primary endpoint
18 June 2024

18 June 2024

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	58
Start date	15 September 2020
Primary completion	18 June 2024
Estimated completion	18 June 2024
Sites	1 location across United States

Drugs / interventions tested

Daily oral vitamin D3, 3,333 IU — full drug profile →
Monthly oral vitamin D3, 100,000 IU — full drug profile →
Placebo oral tablet — full drug profile →

Conditions studied

Sickle Cell Disease — all drugs for Sickle Cell Disease →
Anemia, Sickle Cell — all drugs for Anemia, Sickle Cell →
Anemia, Hemolytic, Congenital — all drugs for Anemia, Hemolytic, Congenital →
Respiratory Tract Diseases — all drugs for Respiratory Tract Diseases →

Sponsor

Columbia University

Who can join

Adults 3 to 20, any sex, with Sickle Cell Disease or Anemia, Sickle Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Annual Rate of Respiratory Events Primary · Month 12, Month 24

Respiratory events will be calculated as the sum of respiratory infection, asthma exacerbation, and acute chest syndrome, as ascertained by use of a validated questionnaire.

Treatment Year 1

Group	Value	95% CI
Daily Oral Vitamin D3	3.3	± 2.1
Monthly Bolus Oral Vitamin D3	3.3	± 2.6

Treatment Year 2

Group	Value	95% CI
Daily Oral Vitamin D3	3.4	± 1.7
Monthly Bolus Oral Vitamin D3	3.2	± 2.4

Mean Forced Vital Capacity (FVC % Predicted) Secondary · Baseline, Month 24

This is to measure the forced vital capacity (FVC; % predicted) at baseline and at month 24. Forced Vital Capacity (FVC) is a key measure of lung function that indicates the total volume of air a person can forcefully exhale after taking a deep breath. It is calculated using spirometry, which assesses lung capacity and helps diagnose respiratory conditions. Predicted FVC: The FVC is compared to predicted values based on age, height, and sex to determine if it is within the normal range (80% or more of predicted). Interpretation: A low FVC may indicate obstruction (e.g., asthma or COPD), while

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	86.3	± 9.4
Monthly Bolus Oral Vitamin D3	84.3	± 13.2

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	83.2	± 9.9
Monthly Bolus Oral Vitamin D3	88.7	± 11.8

Forced Expiratory Volume in 1 Second (FEV1) Secondary · Baseline, Month 24

Forced Expiratory Volume in 1 second (FEV1; % predicted) at baseline and at month 24.

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	84.6	± 9.2
Monthly Bolus Oral Vitamin D3	84.4	± 12.5

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	85.5	± 12.6
Monthly Bolus Oral Vitamin D3	90.8	± 12.9

Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity Ratio Secondary · Baseline, Month 24

Forced Expiratory Volume in 1 second (FEV1; % predicted)/Forced Vital Capacity (FVC) \[FEV1/FVC\] % predicted at baseline and month 24

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	97.9	± 6.5
Monthly Bolus Oral Vitamin D3	100.1	± 8.0

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	97.5	± 8.0
Monthly Bolus Oral Vitamin D3	97.7	± 9.8

Forced Expiratory Flow at 25%-75% Vital Capacity (FEF25-75, % Predicted) Secondary · Baseline, Month 24

Forced Expiratory Flow at 25%-75% vital capacity (FEF25-75) % predicted at baseline and month 24 .

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	80.9	± 22.3
Monthly Bolus Oral Vitamin D3	86.6	± 24.8

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	81.1	± 26.5
Monthly Bolus Oral Vitamin D3	83.7	± 25.0

Ratio of Residual Lung Volume (RV) to Total Lung Capacity (TLC) Secondary · Baseline, Month 24

Ratio of Residual Lung Volume (RV) to Total Lung Capacity (RV/TLC) at baseline and month 24.

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	121.0	± 28.2
Monthly Bolus Oral Vitamin D3	101.2	± 28.9

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	106.9	± 34.6
Monthly Bolus Oral Vitamin D3	109.1	± 19.0

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Secondary · Baseline, Month 24

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO; % predicted) at baseline and month 24

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	87.3	± 10.3
Monthly Bolus Oral Vitamin D3	85.3	± 15.8

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	86.5	± 12.5
Monthly Bolus Oral Vitamin D3	90.0	± 14.1

Neutrophil Count Secondary · Baseline, Month 12, Month 24

Blood Neutrophil Count in percentage at baseline, month 12 and month 24

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	45.8	± 13.5
Monthly Bolus Oral Vitamin D3	43.9	± 9.6

Month 12

Group	Value	95% CI
Daily Oral Vitamin D3	47.7	± 13.8
Monthly Bolus Oral Vitamin D3	43.0	± 11.0

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	45.5	± 14.8
Monthly Bolus Oral Vitamin D3	46.8	± 12.0

Platelet Count Secondary · Baseline, Month 12, Month 24

Blood Platelet Count (Platelets\*10\^3/ per μL) at baseline, month 12 and month 24

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	355.1	± 191.1
Monthly Bolus Oral Vitamin D3	376.2	± 242.0

Month 12

Group	Value	95% CI
Daily Oral Vitamin D3	390.0	± 125.0
Monthly Bolus Oral Vitamin D3	387.2	± 191.8

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	398.9	± 157.3
Monthly Bolus Oral Vitamin D3	359.9	± 150.1

Serum C-reactive Protein (CRP) Secondary · Baseline, Month 12, Month 24

Serum C-reactive protein (CRP; mg/L) at baseline, month 12 and month 24

Baseline

Group	Value	95% CI
Daily Oral Vitamin D3	2.1	± 2.6
Monthly Bolus Oral Vitamin D3	2.9	± 3.7

Month 12

Group	Value	95% CI
Daily Oral Vitamin D3	5.9	± 13.7
Monthly Bolus Oral Vitamin D3	3.6	± 5.0

Month 24

Group	Value	95% CI
Daily Oral Vitamin D3	3.0	± 2.9
Monthly Bolus Oral Vitamin D3	4.6	± 7.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Daily Oral Vitamin D3

Serious: 8/27 (30%)

Deaths: 0/27

Monthly Bolus Oral Vitamin D3

Serious: 3/31 (10%)

Deaths: 0/31

Serious adverse events (6 terms)

Reaction	System	Daily Oral Vitamin D3	Monthly Bolus Oral Vitamin…
Pain syndrome	General disorders	—	—
Acute chest syndrome	General disorders	—	—
Splenic sequestration	Surgical and medical procedures	—	—
Bone infection	Infections and infestations	—	—
Clinical sepsis	Infections and infestations	—	—
COVID-19	Infections and infestations	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Daily Oral Vitamin D3	Monthly Bolus Oral Vitamin…
Pain syndrome	General disorders	—	—
Upper respiratory infection	Infections and infestations	—	—

Most-reported serious reactions: Pain syndrome, Acute chest syndrome, Splenic sequestration, Bone infection, Clinical sepsis, COVID-19.

Data from ClinicalTrials.gov NCT04170348 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The importance of vitamin d metabolism as a potential prophylactic, immunoregulatory and neuroprotective treatment for COVID-19.
Xu Y, Baylink DJ, Chen CS, Reeves ME, et al · · 2020 · cited 100× · PMID 32847594 · DOI 10.1186/s12967-020-02488-5
Vitamin D supplementation for sickle cell disease.
Soe HHK, Abas AB, Than NN, Ni H, et al · · 2020 · cited 7× · PMID 32462740 · DOI 10.1002/14651858.cd010858.pub3

Verify or expand the search:

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

NCT07369024 — Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults · Phase 2 · recruiting
NCT06016634 — Alendronate for Osteonecrosis in Adults With Sickle Cell Disease · Phase 2 · recruiting
NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting

Other Columbia University trials

Trials by the same sponsor.

NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04170348 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 24 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04170348.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04170348: ViDAS-2

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Sickle Cell Disease

Other Columbia University trials

Verify against primary sources