Please select the eligibility criteria that correspond to the clinical trial below.
Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Brief Summary: Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.


Options:
A: 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)
B: Principal Inclusion Criteria:

* Medical record diagnosis of asthma
* Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
* If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
* Able to give written informed consent to participate in the study

Principal Exclusion Criteria:

* Diagnosis of COPD
* Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
* Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
* Treatment with any investigational medical product or device up to 4 months before first dose of IMP
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L
* Smoking history \>15 pack-years
C: Inclusion Criteria:

1. Healthy children by parental report
2. Have reached their 1st birthday but not past their 6th birthday
3. Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
4. Parents provide informed consent to participate.

Exclusion Criteria:

1. Children with gestational age \< 32 weeks
2. Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection
3. Children with a sibling participating in the study to reduce clustering effects.
D: Principal Inclusion Criteria:

* Medical record diagnosis of COPD, emphysema or bronchitis
* Post-bronchodilator FEV1 / FVC \< 70% or post-bronchodilator FEV1 / slow VC \< 70%
* Post-bronchodilator FEV1 \< 80% predicted
* Age ≥ 40 years on day of first dose of IMP
* Smoking history ≥ 15 pack-years
* If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
* Able to give written informed consent to participate

Exclusion Criteria:

* Current diagnosis of asthma
* Known clinically significant bronchiectasis
* Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP
* Treatment with any investigational medical product or device up to 4 months before first dose of IMP
* Breastfeeding, pregnant or planning a pregnancy
* Baseline corrected serum calcium \> 2.65 mmol/L
* Baseline serum creatinine \> 125 micromol/L

Answer: C