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

Phase 4

Recruiting

• Conditions: Acute Respiratory Infection; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Normal development and function of the immune system; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12618001174279
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-16
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

Mother
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

Exclusion Criteria

Mother
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

Infant
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified