Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02112734
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
12 Weeks
Study:
NCT02112734
Study Brief:
Protocol Section:
NCT02112734