Last reviewed 2024-08-09 · How we verify
Home › Trials › NCT01443728 NCT01443728
Vitamin D for Sickle-cell Respiratory Complications
On this page:
Summary Quick facts Who can join Endpoints Results Adverse events Publications Related trials Sources
Completed
Phase 2
Results posted
Last updated 9 August 2024
What this trial tests
Phase 2 trial testing Experimental: Vitamin D3 100,000 IU in Sickle Cell Disease in 70 participants. Completed in 15 February 2015.
Timeline
13 December 2011
Primary endpoint
15 February 2015
Quick facts
Lead sponsor Gary M Brittenham, MD Phase Phase 2 Status Completed Study type INTERVENTIONAL Allocation randomized Design parallel Masking quadruple Primary purpose treatment Enrollment 70 Start date 13 December 2011 Primary completion 20 June 2013 Estimated completion 15 February 2015 Sites 1 location across United States
Drugs / interventions tested
Conditions studied
Sponsor
Gary M Brittenham, MD
Who can join
Adults 3 to 20, any sex, with Sickle Cell Disease or Vitamin D Deficiency. 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.
Mean Annual Rate of Respiratory Events
Primary
· Up to 2 years
Defined as respiratory infection, acute asthma exacerbation, and acute chest syndrome.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 3.91 ± 0.35 Vitamin D3 12,000 IU 4.34 ± 0.35
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 3.34 ± 0.37 Vitamin D3 12,000 IU 4.28 ± 0.36
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 1.54 ± 0.37 Vitamin D3 12,000 IU 1.49 ± 0.37
Mean 25-Hydroxyvitamin D (25-OHD)
Secondary
· 2 years
The overall mean serum 25-OHD concentration will be measured for both groups.
Group Value 95% CI Vitamin D3 100,000 IU 36.1 14 – 38 Vitamin D3 12,000 IU 19.1 13 – 20
Forced Vital Capacity (FVC)
Secondary
· Up to 2 years
Percent predicted forced vital capacity will be calculated for both groups.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 85.5 ± 2.8 Vitamin D3 12,000 IU 90.2 ± 2.3
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 85.2 ± 2.7 Vitamin D3 12,000 IU 92.4 ± 2.3
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 85.0 ± 2.5 Vitamin D3 12,000 IU 92.1 ± 2.5
Forced Expiratory Volume (FEV) in 1 Second (FEV1)
Secondary
· Up to 2 years
Percent predicted forced expiratory volume in 1 second will be calculated for both groups.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 80.4 ± 2.4 Vitamin D3 12,000 IU 84.9 ± 2.3
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 79.1 ± 2.7 Vitamin D3 12,000 IU 85.3 ± 2.1
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 78.9 ± 2.8 Vitamin D3 12,000 IU 84.5 ± 2.0
FEV1/FVC Ratio
Secondary
· Up to 2 years
The ratio of FEV1 to FVC will be calculated (in percentage).
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 84.0 ± 1.5 Vitamin D3 12,000 IU 83.3 ± 1.5
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 82.6 ± 1.0 Vitamin D3 12,000 IU 81.7 ± 1.3
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 82.2 ± 1.5 Vitamin D3 12,000 IU 81.6 ± 1.2
FEF 25-75
Secondary
· Up to 2 years
Percent predicted forced expiratory flow (FEF) during expiration of 25 to 75% of the FVC will be calculated.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 69.8 ± 5.2 Vitamin D3 12,000 IU 68.8 ± 4.9
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 62.9 ± 4.4 Vitamin D3 12,000 IU 64.8 ± 4.3
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 62.8 ± 4.4 Vitamin D3 12,000 IU 65.6 ± 4.3
RV/TLC Ratio
Secondary
· Up to 2 years
The ratio of residual volume (RV) to total lung capacity (TLC) will be calculated (in percentage).
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 26.9 ± 1.3 Vitamin D3 12,000 IU 25.1 ± 1.6
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 25.4 ± 1.8 Vitamin D3 12,000 IU 22.6 ± 1.9
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 22.8 ± 1.6 Vitamin D3 12,000 IU 21.8 ± 1.9
DLCO
Secondary
· Up to 2 years
Percent predicted of the diffusing capacity for carbon monoxide in the lungs (DLCO) will be measured.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 68.0 ± 3.2 Vitamin D3 12,000 IU 72.3 ± 3.9
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 62.9 ± 3.2 Vitamin D3 12,000 IU 67.8 ± 2.4
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 68.1 ± 3.8 Vitamin D3 12,000 IU 72.9 ± 2.9
FeNO
Secondary
· Up to 2 years
Fractional exhaled nitric oxide (FeNO) will be measured in parts per billion (ppb).
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 19.3 ± 2.7 Vitamin D3 12,000 IU 16.9 ± 2.1
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 20.5 ± 3.5 Vitamin D3 12,000 IU 16.1 ± 2.1
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 18.1 ± 2.7 Vitamin D3 12,000 IU 16.4 ± 2.4
MIP
Secondary
· Up to 2 years
Maximum inspiratory pressure (MIP) will be measured.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 69.1 ± 5.6 Vitamin D3 12,000 IU 59.9 ± 5.3
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 78.7 ± 6.1 Vitamin D3 12,000 IU 80.4 ± 6.3
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 77.4 ± 5.0 Vitamin D3 12,000 IU 74.6 ± 4.7
MEP
Secondary
· Up to 2 years
Maximum expiratory pressure (MEP) will be measured.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 66.3 ± 3.9 Vitamin D3 12,000 IU 66.3 ± 5.4
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 60.4 ± 3.3 Vitamin D3 12,000 IU 57.3 ± 3.1
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 58.7 ± 3.4 Vitamin D3 12,000 IU 56.2 ± 4.0
Hand-grip, Right
Secondary
· Up to 2 years
Muscle strength was measured by looking at hand-grip strength in the right hand.
Baseline
Group Value 95% CI Vitamin D3 100,000 IU 21.2 ± 3.2 Vitamin D3 12,000 IU 16.9 ± 2.2
Year 1
Group Value 95% CI Vitamin D3 100,000 IU 20.6 ± 3.0 Vitamin D3 12,000 IU 16.6 ± 2.4
Year 2
Group Value 95% CI Vitamin D3 100,000 IU 23.8 ± 4.1 Vitamin D3 12,000 IU 17.4 ± 2.9
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.
Vitamin D3 100,000 IU
Serious: 11/31 (35%)
Deaths: —
Vitamin D3 12,000 IU
Serious: 6/31 (19%)
Deaths: —
Serious adverse events (12 terms) Reaction System Vitamin D3 100,000 IU Vitamin D3 12,000 IU Pain Syndrome (Grade 3 & 4) General disorders — — Acute Chest Syndrome General disorders — — Mucosal Infection (Herpetic Gingivostomatitis) Infections and infestations — — Stroke Nervous system disorders — — Cholecystitis Gastrointestinal disorders — — Asthma Exacerbation Respiratory, thoracic and mediastinal disorders — — Cholecystitis Gastrointestinal disorders — — Hypoxemia Blood and lymphatic system disorders — — Pneumonia General disorders — — Sepsis Blood and lymphatic system disorders — — Varicella Zoster Infections and infestations — — Cervical Lymphadenitis Blood and lymphatic system disorders — —
Other adverse events (17 terms — click to expand) Reaction System Vitamin D3 100,000 IU Vitamin D3 12,000 IU Pain Syndrome (Grade 1 or 2) General disorders — — Fever General disorders — — Acute Chest Syndrome (Grade 1 & 2) General disorders — — Upper Respiratory Infection Infections and infestations — — Anemia Blood and lymphatic system disorders — — Streptococcal Pharyngitis Infections and infestations — — Influenza A/B Infections and infestations — — Blood Bilirubin Increased Blood and lymphatic system disorders — — Injury Injury, poisoning and procedural complications — — Asthma Exacerbation Respiratory, thoracic and mediastinal disorders — — Acute Pharyngitis General disorders — — Urinary Tract Infection Renal and urinary disorders — — Constipation Gastrointestinal disorders — — Leukocytosis Blood and lymphatic system disorders — — Acute Otitis Media Infections and infestations — — Seizure General disorders — — Headache General disorders — —
Most-reported serious reactions: Pain Syndrome (Grade 3 & 4) , Acute Chest Syndrome , Mucosal Infection (Herpetic Gingivostomatitis) , Stroke , Cholecystitis , Asthma Exacerbation , Cholecystitis , Hypoxemia .
Data from ClinicalTrials.gov NCT01443728 adverse events section .
Sponsor's own description
This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month.
Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Randomized phase 2 trial of monthly vitamin D to prevent respiratory complications in children with sickle cell disease.
Lee MT, Kattan M, Fennoy I, Arpadi SM, et al ·
· 2018
· cited 27×
· PMID 29712666
· DOI 10.1182/bloodadvances.2017013979
Vitamin D supplementation for sickle cell disease.
Soe HH, Abas AB, Than NN, Ni H, et al ·
· 2017
· cited 19×
· PMID 28105733
· DOI 10.1002/14651858.cd010858.pub2
Verify or expand the search:
Other recruiting trials for Sickle Cell Disease
Currently open trials in the same condition.
NCT07369024 · Phase 2
· recruiting
NCT06016634 · Phase 2
· recruiting
NCT06260891 · Phase 2
· recruiting
NCT07222475 · NA
· recruiting
NCT07224360 · Phase 2
· recruiting
Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT01443728 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Gary M Brittenham, MDLast refreshed : 9 August 2024
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/NCT01443728.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing
Not medical advice. Information on this page is collated from primary regulatory and clinical-trial sources for research purposes. It is not a substitute for consultation with a licensed healthcare professional. See our editorial policy for sourcing and methodology.