Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin D Intervention in Infants
Brief Summary: The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.


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:

* age 1-5 years
* physician-diagnosed asthma as per the Global Initiative for Asthma (GINA) guidelines
* URTIs as the main asthma trigger (parental report)
* ≥4 URTIs in the past 12 months (parental report)
* ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months

Exclusion Criteria:

* intake or intention to use more than 400 IU/day of vitamin D supplement
* extreme prematurity (\<28 weeks gestation)
* infants \<12 months of age
* no vitamin D supplementation when breast-fed
* recent (\<1 year) immigrants from a region at high risk of rickets
* children with vitamin D restrictive diets e.g. vegans
* other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
* condition(s) that alter calcium or vitamin D metabolism/absorption (hypo/hyperparathyroidism, kidney/liver disease, inflammatory bowel disease)
* medications that interfere with vitamin D metabolism (anti-epileptics, diuretics, antacids, anti-fungal drug)
* vitamin D supplementation \>1000 IU/ day in last 3 months
* anticipated difficult follow-up (unable to attend clinic visits; plan to leave the province).
C: Inclusion Criteria:

* Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

Exclusion Criteria:

* Non Caucasian mother
* Any continuous regular medication of mother
* Treatment at neonatal intensive care unit
* Antibiotic treatment of the infant
* Congenital malformations of the newborn
* Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
* Glucose infusion of the newborn
* Neurological symptoms of the newborn
* Phototherapy for jaundice of the newborn
* Need for nasogastric feeding of the newborn
D: Inclusion Criteria:

* HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
* Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
* Age 3 years through 18 years
* Voluntary informed consent

Exclusion Criteria:

* Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
* Active participation in another treatment trial
* Serum calcium \< 2mmol/L at baseline

Answer: C