Please select the eligibility criteria that correspond to the clinical trial below.
Title: Can Vitamin D Supplementation Prevent Food Allergy in Infants? the VITALITY Trial
Brief Summary: We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.


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:

* 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
C: Inclusion Criteria:

* greater than 32 weeks gestation,
* exclusively formula fed.

Exclusion Criteria:

* less than 32 weeks gestation,
* less than 1500 grams,
* recieving maternal breast milk,
* recieving parenteral nutrition,
* congenital anomolies,
* disorders of vitamin D metabolism,
* inborn errors of metabolism,
* seizure disorders,
* parathroid disease,
* liver, GI tract, or kidney disease, and
* disorders of calcium metabolism.
D: Inclusion Criteria:

Each participant must meet the following criteria to be included in this study:

* Healthy, term (born no earlier than 2 weeks before estimated date of delivery), predominantly breastfeeding infants aged 6 to 12 weeks (inclusive) who are expected to be predominantly breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend/wish to breastfeed until your infant is at least 6 months of age.' Up to one bottle (approx. 120mL) of formula per 24 hours at the time of screening is acceptable, as this will contain \<100 IU vitamin D.
* Has a parent/legally acceptable representative (LAR) capable of understanding the informed consent document and providing consent on the subject's behalf,
* The parent must expect to be able to complete 4 online questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing (+/- food challenge) at The Royal Children's Hospital at 12 months of age.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

* Infants who are currently receiving vitamin D supplementation
* Infants on medication that interferes with vitamin D metabolism
* Poor health due to a current or past significant disease state or congenital abnormality.
* Prematurity \<37 weeks/low birth weight \<2500 g/Small for gestational age (SGA)
* Unable to provide consent without the aid of an interpreter.
* Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.

Answer: D