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

Menzies School of Health Research0 个研究点目标入组 314 人开始时间: 2018年7月16日最近更新: 2024年4月8日

适应症

试验速览

暂无简介。

•1. Pregnant with current gestation of 28 to 34 weeks, inclusive.
•2. Aged over 17 to less than or equal to 40 years at the time of written informed consent
•3. Aboriginal and/or Torres Strait Islander descent
•4. 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

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

发起方