The effects of vitamin D supplementation in infancy on immune development

In infants with a family history of allergic disease, vitamin D supplementation from birth to 6 months of age will be compared to no vitamin D supplementation on the outcomes of infant vitamin D status and immune function.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000787886

Acronym

VITAL Trial

Enrollment

195

Registered

2012-07-25

Start date

2012-10-09

Completion date

2017-01-23

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Allergies have been on the rise in Australia, and evidence suggests vitamin D may play a role. Vitamin D has been shown to influence the immune system and has been linked to asthma, eczema and food allergies. This study will help determine whether vitamin D supplements given to infants will alter the risk of development of allergic disease.

Interventions

400 IU per day of vitamin D3-Cholecalciferol contained within coconut and palm kernel oil and to be given to the infant as one drop of liquid (0.03ml) per day from birth to 6 months of age.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to 1 Months

Healthy volunteers

Yes

Inclusion criteria

Term singleton infants who have a first degree relative with a history of allergic disease.

Exclusion criteria

Maternal vitamin D serum concentration <50 nmol/L or >100 nmol/L between 36-40 weeks gestation. Maternal smoking during pregnancy.

Outcome results