RecruitingPhase 4ACTRN12618001174279

Vitamin D supplementation to prevent acute respiratory infections among Indigenous children in the Northern Territory: a randomised controlled trial

Sponsor

Menzies School of Health Research

Enrollment

314 participants

Start Date

Feb 5, 2019

Study Type

Interventional

Conditions

Acute Respiratory Infection

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

Sex: Both males and femalesMin Age: 0 YearssMax Age: 40 Yearss

Inclusion Criteria8

Mother
Pregnant with current gestation of 28 to 34 weeks, inclusive.
Aged over 17 to less than or equal to 40 years at the time of written informed consent
Aboriginal and/or Torres Strait Islander descent
A resident in urban Darwin, Alice Springs or one of the participating communities at the time of enrolment and intending to stay in a study community until the infants is 12 months of age
Eligibility will include:
Dichorionic Diamniotic (DCDA) twin pregnancies (two amniotic sacs, two or shared placentas)
Previously enrolled mothers

Exclusion Criteria20

Mother
Enrolled in other studies that may influence the outcomes of this study
Taking prescribed vitamin D in pregnancy >400 IU/day (or equivalent)
Self-supplementing with vitamin D >400 IU/day (or equivalent) and not willing to cease
Hypercalcaemia this pregnancy (serum calcium >2.8 mmol/L or a urinary calcium:creatinine ratio >1 on two occasions)
Uncontrolled thyroid disorders influencing parathyroid hormone
Chronic kidney disease (greater than or equal to stage 4)
Known anaphylactic allergies
Current drug use this pregnancy (excluding marijuana and alcohol)
History of or current kidney/bladder stones
Monohorionic Diamniotic (MCDA) twins (one placenta, two amniotic sacs)
Clinician approval to commence study medicine will be sought for:
History >2 preterm births <34 weeks gestation
Low risk Dichorionic Diamniotic (DCDA) twins (two amniotic sacs, two or shared placentas)
Other high risk pregnancies
Infant
Clinician approval to commence study medicine will be sought for those:
Born <36 weeks
Admitted to intensive or special care units
With a congenital anomaly

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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

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.