Asthma Clinical Trial
— ViDAS-2Official title:
Daily Vitamin D for Sickle-cell Respiratory Complications
Verified date | March 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 69 |
Est. completion date | February 28, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 20 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of sickle cell disease (Hb SS, Hb SC, Hb S-Beta-thalassemia) 2. Age 3-20 years old Exclusion Criteria: 1. Patient unwilling or unable to provide written informed consent (and assent, if applicable) 2. Patient unable or unwilling to comply with requirements of the clinical trial 3. Participation in another clinical trial 4. Current diagnosis of rickets 5. History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia 6. Current use of corticosteroids, excluding inhaled steroids 7. Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine) 8. Therapy with thiazide diuretics or lithium carbonate 9. Known liver or renal disease 10. Patients taking medications for pulmonary complications of sickle cell disease not on a stable dose of medications, as defined by a change in medications or doses within the three months prior to study entry 11. Patients on chronic red blood cell transfusion therapy |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Gary M Brittenham, MD |
United States,
De A, Anekwe CV, Kattan M, Yao Y, Jin Z, Brittenham GM, Lee MT. Validation of a Questionnaire to Identify Respiratory Tract Infections in Children With Sickle Cell Disease. J Pediatr Hematol Oncol. 2021 Jul 1;43(5):e661-e665. doi: 10.1097/MPH.0000000000002164. — View Citation
Lee MT, Kattan M, Fennoy I, Arpadi SM, Miller RL, Cremers S, McMahon DJ, Nieves JW, Brittenham GM. Randomized phase 2 trial of monthly vitamin D to prevent respiratory complications in children with sickle cell disease. Blood Adv. 2018 May 8;2(9):969-978. doi: 10.1182/bloodadvances.2017013979. — View Citation
Williams KM, Lee MT, Licursi M, Brittenham GM, Fennoy I. Response to Long-term Vitamin D Therapy for Bone Disease in Children With Sickle Cell Disease. J Pediatr Hematol Oncol. 2018 Aug;40(6):458-461. doi: 10.1097/MPH.0000000000001155. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Respiratory Events | Annual rate of 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. | Screening up to month 24 | |
Secondary | Change in Forced Vital Capacity (FVC) | Change forced vital capacity (FVC; % predicted) from baseline | Baseline and month 24 | |
Secondary | Change in Forced Expiratory Volume in 1 second (FEV1) | Change in Forced Expiratory Volume in 1 second (FEV1; % predicted) from baseline. | Baseline and month 24 | |
Secondary | Change in Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity ratio | Change in Forced Expiratory Volume in 1 second (FEV1; % predicted)/Forced Vital Capacity (FVC) [FEV1/FVC] % predicted from baseline. | Baseline and month 24 | |
Secondary | Change in Forced Expiratory Flow at 25%-75% vital capacity (FEF25-75) | Change in Forced Expiratory Flow at 25%-75% vital capacity (FEF25-75) % predicted from baseline. | Baseline and month 24 | |
Secondary | Change in ratio of Residual Lung Volume (RV) to Total Lung Capacity (TLC) | Change in per cent of the ratio of Residual Lung Volume (RV) to Total Lung Capacity (RV/TLC) from baseline. | Baseline and month 24 | |
Secondary | Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) | Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO; % predicted) from baseline | Baseline and month 24 | |
Secondary | Change in Fractional Concentration of Exhaled Nitric Oxide (FENO) | Change in Fractional Concentration of Exhaled Nitric Oxide (FENO) in parts per billion (ppb) from baseline | Baseline and month 24 | |
Secondary | Change in Maximum Inspiratory Pressure (MIP) | Change in Maximum Inspiratory Pressure (MIP; cm H2O) from baseline | Baseline and month 24 | |
Secondary | Change in Maximum Expiratory Pressure (MEP) | Change in Maximum Expiratory Pressure (MEP; cm H2O) from baseline | Baseline and month 24 | |
Secondary | Change in interleukin 2 (IL 2) concentration | Change in serum interleukin 2 concentration (IL 2; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 4 (IL 4) concentration | Change in serum interleukin 4 concentration (IL 4; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 5 (IL 5) concentration | Change in serum interleukin 5 concentration (IL 5; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 13 (IL 13) concentration | Change in serum interleukin 13 concentration (IL 13; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in interferon gamma (IFN gamma). concentration | Change in serum interferon gamma concentration (IFN gamma; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 10 (IL 10) concentration | Change in serum interleukin 10 concentration (Iinterleukin 10; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in Transforming Growth Factor beta (TGF beta) | Change in serum Transforming Growth Factor beta (TGF beta; pg/mL ) from baseline | Baseline up to month 24 | |
Secondary | Change in blood hemoglobin concentration (Hb) | Change in blood hemoglobin concentration (Hb; g/dL) from baseline | Baseline up to month 24 | |
Secondary | Change in blood platelet concentration | Change in blood platelet concentration (platelets/mL) from baseline | Baseline up to month 24 | |
Secondary | Change in serum C-reactive protein (CRP) | Change in serum C-reactive protein (CRP; mg/L) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 1alpha (IL 1alpha) concentration | Change in serum interleukin 1alpha (IL 1alpha; pg/mL) from baseline | Baseline up to month 24 | |
Secondary | Change in interleukin 1beta (IL 1beta) concentration | Change in serum interleukin 1beta (IL 1beta; pg/mL) from baseline | Baseline up to month 24 | |
Secondary | Change in Tumor Necrosis Factor alpha (TNF alpha) concentration | Change in serum Tumor Necrosis Factor alpha (TNF alpha; pg/mL) from baseline | Baseline up to month 24 | |
Secondary | Change in C-terminal telopeptides of Type I collagen (CTX) | Change in serum C-terminal telopeptides of Type I collagen (CTX; ng/mL) from baseline | Baseline up to month 24 | |
Secondary | Change in intact N-terminal propeptide of type I procollagen (P1NP) | Chang in serum intact N-terminal propeptide of type I procollagen (P1NP; µg/L) from baseline.= | Baseline up to month 24 |
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