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:

* Preterm Infants (28-37 wk gestational age)
* Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

  1. Temperature instability (hypothermia, hyperthermia);
  2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  3. Neurologic (hypotonia, lethargy, seizures);
  4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

* Major congenital anomalies.
* Chromosomal anomalies.
* Known inborn error(s) of metabolism
B: 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.
C: Inclusion Criteria:

* Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

* Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
* Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
D: Inclusion criteria:

1. 28 0/7-36 6/7 weeks gestational age (GA) at birth;
2. family identifies the child as black or African American;
3. \< 28 days of supplemental oxygen (subsequent oxygen therapy for \< 72 hrs for a brief subsequent illness or surgery will be allowed);
4. admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and
5. \< 40 weeks corrected GA at enrollment.

Exclusion criteria:

1. BPD (\> 28 days of supplemental oxygen);
2. pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline phosphatase \> 700;
3. history of fracture;
4. gastrointestinal surgery, including for NEC;
5. known gastrointestinal malabsorption;
6. major congenital anomaly;
7. congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia, swallowing disorder, bronchopulmonary sequestration);
8. documented wheezing or stridor prior to enrollment;
9. previous vit. D supplementation with \> 400 IU/day;
10. family plans to move more than 60 miles from CWRU or other pre-defined radius at other sites;
11. baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and
12. baseline 25(OH) D level \< 10 ng/ml.

Answer: B