Please select the eligibility criteria that correspond to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: * This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States
* Participants who live in selected metropolitan areas of the U.S. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.
B: Inclusion Criteria:

* Men and women 18 years of age and older
* Physician-diagnosed asthma for at least previous 12 months
* Asthma confirmed by: (a) β-agonist reversibility of forced expiratory volume in 1 second (FEV1) ≥12 % following 180 mcg (4 puffs) levalbuterol at visit 1 OR (b) methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤ 8 mg/ml if not receiving an inhaled corticosteroid or ≤ 16 mg/ml if receiving an inhaled corticosteroid at visit 2. Source documentation for PC20 from an AsthmaNet methacholine challenge completed within 6 months of visit 2 will be accepted.
* Stable asthma controller therapy (inhaled corticosteroid or leukotriene modifier only) dose for past 2 weeks
* FEV1 ≥ 50% of predicted at visit 1
* Vitamin D level of less than 30 ng/ml at visit 0
* Experienced no more than one treatment failure in the VIDA run-in or oral corticosteroid (OCS) response periods on previous enrollments
* For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study

Exclusion Criteria:

* Taking vitamin D supplements containing \> 1000 IU/day of vitamin D
* Taking \>2500 mg/day calcium supplements
* Chronic oral corticosteroid therapy
* Chronic inhaled corticosteroid therapy \> 1,000 mcg of fluticasone daily or the equivalent
* History of physician-diagnosed nephrolithiasis
* Use of concomitant medications that alter vitamin D metabolism - phenytoin, phenobarbital, cardiac glycosides; or absorption - orlistat, cholestyramine, colestipol; or those that interfere with study endpoints
* Impaired renal function (GFR \< 30 ml/min)
* Asthma exacerbation within past 4 weeks requiring systemic corticosteroids
* Respiratory tract infection within past 4 weeks
* Chronic diseases (other than asthma)
* History of cigarette smoking within the past 1 year or \> 10 pack years total
* Serum calcium greater than 10.2 mg/dl on entry
* Urine calcium/creatinine ratio greater than 0.37 (urinary Ca and Creat in mg)
C: Inclusion Criteria:

* children aged 1-5 years
* physician-diagnosed asthma as per GINA guidelines
* upper respiratory tract infections as the main asthma exacerbation trigger
* ≥4 respiratory infections in the past 12 months
* ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.

Exclusion Criteria:

* extreme prematurity (\<28 weeks gestation)
* infants \<12 months of age
* breastfed infants with no vitamin D supplementation
* recent (\<1 year) immigrants from countries where rickets and malnutrition prevalent
* other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
* endocrine disorder of calcium/ vitamin D metabolism
* disorder/ disease with associated malabsorption (inflammatory bowel disease)
* kidney/ liver disease
* sickle cell anemia
* medications known to interfere with bone metabolism/ vitamin D levels
* vitamin D supplementation \>1000 IU/ day in past 3 months
* unable to attend medical visit in 3-4 months
* plan to leave the province during the next 6 months.
D: Inclusion Criteria:

* Diagnosis of sickle cell disease (HbSS, HbSC, HbS Beta-thalassemia)
* Age 3 to 20 years old

Exclusion Criteria:

* Patient (or parent or guardian) unwilling or unable to provide written informed consent (and assent, if applicable)
* Patient unable or unwilling to comply with requirements of the clinical trial
* Participation in other therapeutic clinical trial
* Current diagnosis of rickets
* History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia
* Current use of corticosteroids, excluding inhaled steroids
* Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)
* Therapy with thiazide diuretics or lithium carbonate
* Known liver or renal disease
* 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
* Patients on chronic red blood cell transfusion therapy
* Absence of baseline record of respiratory events (respiratory infections, asthma exacerbations, episodes of acute chest syndrome) for the preceding year
* Pregnancy

Answer: A