Vitamin D supplementation to prevent acute respiratory infections among Indigenous children in the Northern Territory: a randomised controlled trial
Menzies School of Health Research
314 participants
Feb 5, 2019
Interventional
Conditions
Summary
A double-blind (allocation concealed) randomised controlled trial conducted among Indigenous mother-infant pairs in the Northern Territory. To determine whether weekly vitamin D supplementation (compared to placebo) given to mothers (between 28 to 34 weeks gestation (inclusive) until birth) and their infants (birth until age 4 months) reduces the incidence of acute respiratory infection (hospitalisations or primary care presentations) in the infants first 12 months of life.
Eligibility
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Interventions
Arm 1: Interventional Group Mother: 0.4 ml (~35 IU/µl) of liquid vitamin D supplement orally once per week, total 14000 IU/week (equivalent 2000 IU/day), from 28-34 weeks gestation (inclusive) until delivery. Infant: 0.2 ml (~21 IU/µl) of liquid vitamin D supplement orally once per week, total 4200 IU/week (equivalent 600 IU/day), from birth until 4 months of age Reduced dose for infants discharged from hospital with a routine recommendation to take oral vitamin D 400 IU/day: Infant: 0.14 ml (~21 IU/µl) of liquid vitamin D supplement orally once per week, total of 3000 IU/week (equivalent to 430 IU/day), from birth until 4 months of age. Maximum possible dose received by infant is 5800 IU/week (830 IU/day). Safe tolerable upper limit for neonates is 7000 IU/week. Administration of study medication: Participants will be allocated to weekly supervised administration of study medication. Study staff or midwives, child health nurses and community workers in allocated clinics will be tasked with locating/recalling participants and administering the supervised dose of study medication. Those participants who cannot be located within 3 days of scheduled dose will be considered as having a ‘missed dose’. These participants will move on to the next dose. There will be no catch up dose.
Locations(3)
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ACTRN12618001174279