None listed
Conditions
Brief summary
Evidence shows that Vitamin D and probiotic supplementation has a beneficial effect on a child’s immune system. This randomised placebo controlled parallel trial aims to examine the effect of 2-month supplementation with Vitamin D and probiotics on selected physiological and behavioural responses in an infant group at time of their first routine childhood immunisation. This project will assess daily temperature and sleep pattern over two months, and growth, weight at three physician appointments, 4 weeks prior, at the time of vaccination, and 4 weeks after enrolment.
Interventions
Our study will comprise of a double-blind parallel randomised placebo-controlled trial of 8 weeks duration investigating the effect of vitamin D and probiotic supplementation around routine childhood vaccination on physiological and behavioural pattern in 4-24 month-old infants.
The active treatment group will be allocated to 1000 IU Vitamin D3 liquid supplied with a 0.25ml dropper & 2.3g Probiotic powder mixed in milk (breast milk or formula) daily for 2 months.
Each 2.3 g dose (1 level metric
Our study will comprise of a double-blind parallel randomised placebo-controlled trial of 8 weeks duration investigating the effect of vitamin D and probiotic supplementation around routine childhood vaccination on physiological and behavioural pattern in 4-24 month-old infants. The active treatment group will be allocated to 1000 IU Vitamin D3 liquid supplied with a 0.25ml dropper & 2.3g Probiotic powder mixed in milk (breast milk or formula) daily for 2 months. Each 2.3 g dose (1 level metric teaspoon) contains a blend of probiotic strains: 6 billion Lactobacillus rhamnosus (GG) organisms (LGG®) 3.75 billion Lactobacillus acidophilus (NCFM) organisms 3.75 billion Bifidobacterium lactis (Bi-07) organisms The routine childhood vaccination - including Infanrix hexa and Prevenar 13 - will be scheduled in middle (week 4) of the 8 week supplementation regime. Supplementation will commence 4 weeks prior to vaccination (week 0) and continue 4 weeks after vaccination (week 8). Compliance will be assessed by return of supplements, as well as diary entries.
Sponsors
AProf Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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)
Outcome results
None listed