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PREVARID - PREVention of Acute Respiratory Infections with Vitamin D

Does vitamin D supplementation prevent acute respiratory infection health care visits among children under 2 years old? A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000659404
Acronym
PREVARID - PREVention of Acute Respiratory Infections with Vitamin D
Enrollment
300
Registered
2016-05-20
Start date
2016-07-01
Completion date
2017-11-30
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

During the first two years of life a child living in New Zealand (NZ) is more than twice as likely as a child living in England or the United States to require inpatient hospital care for an acute lower respiratory infection (ALRI). In NZ 10% of children <2 years old are hospitalised with an acute respiratory infection with 80% of these being acute lower respiratory infections (ALRI). Respiratory infections account for two-thirds of all infectious disease hospital admissions in this age group. Over 50% of newborns in NZ are vitamin D deficient. We showed that, in Auckland, the risk of vitamin D deficiency from age 6-23 months of age is 7 times greater for Pacific and 3 times greater for Maori compared with European children, and 4 times greater for children living in crowded households. We have recently shown, in a randomised controlled trial (RCT) in Auckland, that vitamin D supplementation given during the last trimester of pregnancy and then from birth to age 6 months prevents acute respiratory infection (ARI) primary care visits from birth to age 18 months. Of the 260 pregnant women enrolled into this trial 49% were Pacific and 24% were Maori. For over a quarter of the children <2 years old who are hospitalised with an ALRI, this is just the first of a series of ALRIs that require inpatient hospital care. In this project we will determine if vitamin D supplementation given to children <2 years old who are hospitalised with an ALRI reduce, in the next 12 months, the number of ARI health care visits they make. We will do this by conducting a hospital based RCT. We will enrol children <2 years old admitted to Starship Children’s Hospital with an ALRI with recruitment occurring over the autumn, winter and spring months (with extension in a second autumn/winter/spring time period if necessary, and randomly assign them to weekly vitamin D supplementation or placebo for 12 months after this ALRI hospital admission. We will follow these children over this 12 month period and describe their respiratory illnesses, nutrition, sunlight exposure and household living conditions. We will identify primary and secondary care ARI visits from primary care records and from the Ministry of Health national hospital event dataset (the National Minimum Dataset). Blood samples will be obtained for measurement of 25(OH)D concentration at enrolment and 6 months after randomisation. Measurement of 25(OH)D concentration at 12 months after enrolment will be done in a random subsample of 10% of the children enrolled in the study. Should this trial show that vitamin D supplementation prevents subsequent health care ARI visits, then such supplementation will be included in the Starship Clinical guidelines as a component of routine and best practice clinical care. These guidelines are used by paediatricians working throughout NZ to inform their care of children admitted to hospital.

Interventions

Determine if weekly vitamin D supplementation with vitamin D (5000 IU) for 12 months after Acute Lower Respiratory Infections (ALRI) hospital admission prevents subsequent health care ARI visits. The study medicine will be in a bottle with a dropper. Each participant will be given 5 drops orally administered of study medicine per week, with all 5 drops given on the same day each week. Adherence will be monitored by weighing the study medicine bottles and by parental interview.

Sponsors

Cure Kids
Lead SponsorOther

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
0 to 2 Years
Healthy volunteers
No

Inclusion criteria

Children will be eligible for enrolment if they are NZ residents, are <2 years old at the time of their ALRI hospital admission and reside in the Auckland District Health Board catchment area.

Exclusion criteria

Children will be ineligible if receiving vitamin D supplements or if they have a complex chronic condition known to be associated with recurrent hospital admission, for example, cystic fibrosis or a tracheostomy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026