Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin D for Sickle-cell Respiratory Complications
Brief Summary: 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


Options:
A: Inclusion Criteria:

* Eligible criteria included patients with mild to moderate atopic dermatitis by SCORAD (Scoring for Atopic Dermatitis) score criteria1,17,18, age between 1-18 years old. All patients had been advised to take normal, dietary product and their activities. They had been advised to discontinue at least 4 weeks of oral corticosteroid, at least 2 weeks of topical corticosteroid or topical calcineurin inhibitor application and at least 6 months of vitamin supplement prior to starting the protocol

Exclusion Criteria:

* The exclusion criteria were to coexisting skin infection on top with AD lesions, known case of primary or secondary immune-compromised host, hepatic or renal disease, those taking vitamin D or nutraceutical supplementation, those continues taking with antibiotics, corticosteroid, immunosuppressive agents, anti-epileptic drugs, thiazide diuretics, proton-pump inhibitors, histamine 2-receptor antagonists at the time of enrollment. Patients who used topical antiseptic or antibiotic products during study period were also excluded. Patients who developed worsening of AD with flare-up of clinical manifestation or SCORAD greater than 40, secondary infection on-top tested lesions were excluded from data analysis.
B: Inclusion Criteria:

* Newborn (corrected gestational age between 36 weeks) up to 18 years
* Has CHD that will require surgery within the next 12 months
* CHD requiring surgical intervention with cardiopulmonary bypass

Exclusion Criteria:

* Born at less than 32 weeks gestational age
* Corrected gestational age of less than 36 weeks
* Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery
* Patient has confirmed or suspected Williams syndrome
* Proposed surgery to take place at another centre (outside of CHEO)
C: 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
D: Inclusion Criteria:

* Healthy singleton newborn infants born at term age of any racial background.
* Infants may be breastfed or formula fed during the study as is safe since the supplement is 400 IU/d and intakes from breast milk or formula will not exceed 400 IU/d for a theoretical total intake of 800 IU/d that is recommended by the Canadian Pediatric Society.

Exclusion Criteria:

* Infants born prematurely, twins or other multiples.
* Unable to nurse or accept the supplement.
* Congenital malformations.
* Parents not fluent enough in English or French to provide written informed consent.

Answer: C