The Vaccination Infant Supplementation (VISS) Study - assessing the effect of vitamin D and probiotic supplementation around vaccination on infant's temperature and sleep pattern.
- Conditions
- immune functionInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12618001992291
- Lead Sponsor
- AProf Dr Karin Ried
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 50
Group 1 (preferred): Infants who have not yet been immunised (age range: 4-24 months).
Group 2: Infants who have been immunised (age range: 4-24 months).
Parents have agreed to have their child immunised.
Normal infant growth as per WHO growth charts
No tympanic temperature > 38 degrees Celsius in the preceding 4 weeks prior to immunisation
Infants currently breastfed (e.g. exclusively or breast and formula fed)
Infants currently not taking supplements (Vitamin D and/or probiotics)
Infants who will remain in the same routine with primary carers for the 2 month study period
Infant has any severe allergies (particularly corn or maize products, as probiotics and placebo powder contains maltodextrin)
Infant has a disease that lowers their immunity (ie. leukaemia, cancer, HIV/AIDs)
Infant is having treatment that lowers immunity (ie. steroids, immunotherapy, chemotherapy)
Infant’s mother is receiving highly immunosuppressive therapy (ie. biological disease modifying anti-rheumatic drugs (bDMARDs)
Infant has had an immunoglobulin injection, received any blood products or blood transfusion)
Infant has had a past history of Guillain-Barre syndrome
Infant has a chronic illness
Infant has a bleeding disorder
Infant is ATSI (Aboriginal Torres Strait Islander)
Infant does not have functional spleen
Infant lives with someone who is immunocompromised (ie. leukaemia, cancer, HIV/AIDS, chemotherapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method