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

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether giving vitamin D supplements to Indigenous mothers during late pregnancy and to their babies in the first four months of life reduces the number of respiratory infections (coughs, colds, chest infections) that babies experience in their first year. Indigenous children in the Northern Territory have high rates of severe respiratory infections, which can lead to hospitalisation. Vitamin D plays an important role in immune function, and many Indigenous Australians have lower vitamin D levels, making this a potentially important and low-risk intervention. Pregnant mothers between 28 and 34 weeks of pregnancy are randomly assigned to receive either weekly vitamin D supplements or a placebo (an identical-looking tablet with no active ingredient). After the baby is born, the baby also receives the allocated supplement or placebo until 4 months of age. Researchers track how many times the baby is seen for respiratory infections at hospitals or health centres in the first 12 months. You may be eligible if you are an Aboriginal and/or Torres Strait Islander woman who is 28 to 34 weeks pregnant and living in or near Darwin, Alice Springs, or one of the participating communities. Women already taking high-dose vitamin D supplements, those with certain kidney conditions or hypercalcaemia, and those enrolled in other studies that might affect outcomes are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.