Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Weeks - 12 Weeks|
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.
- - 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/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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Murdoch Childrens Research Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kirsten Perrett, MD PhD|
|Principal Investigator Affiliation||Murdoch Children's Research Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Comparator: vitamin D
400 IU /daily cholecalciferol/vitamin D
Placebo Comparator: placebo
carrier formulation minus vitamin D
Drug: - Vitamin D
400 IU/daily until age 12 months
Drug: - placebo
identical placebo daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.