None listed
Conditions
Brief summary
In New Zealand the Ministry of Health does not currently recommend vitamin D supplementation in pregnancy or infancy. Vitamin D deficiency is common in New Zealand as are poor health outcomes associated with vitamin D deficiency. Aim: To determine the vitamin D dose in pregnancy and early life that safely and effectively increases serum 25-hydroxy vitamin D (25[OH]D) concentration in infants. Design: A double blind randomised placebo controlled trial of 2 different daily vitamin D doses in pregnancy and early infancy. Outcomes: (1) Provide advice to the Ministry of Health as to the most appropriate vitamin D dose in pregnancy and infancy for New Zealand, and (2) to determine the most appropriate vitamin D dose in pregnancy and infancy for a proposed randomised clinical trial of vitamin D in pregnancy and infancy aimed at reducing infectious diseases in early childhood, and preventing asthma and allergic diseases
Interventions
1. Enrolled mothers will be randomised to receive either placebo or 1000 IU/day or 2000 IU/day of vitamin D3.
2. The infants of these mothers will be randomised to receive placebo, if their mother was randomised to placebo, 400 IU/day (if mother’s dose was 1000 IU/day) or 800 IU/day of vitamin D3 (if mother’s dose was 2000 IU/day).
Vitamin D supplementation and placebo will be an oral liquid medicine
Each enrolled pregnant woman will receive the study medicine from enrollment at apporximately
1. Enrolled mothers will be randomised to receive either placebo or 1000 IU/day or 2000 IU/day of vitamin D3. 2. The infants of these mothers will be randomised to receive placebo, if their mother was randomised to placebo, 400 IU/day (if mother’s dose was 1000 IU/day) or 800 IU/day of vitamin D3 (if mother’s dose was 2000 IU/day). Vitamin D supplementation and placebo will be an oral liquid medicine Each enrolled pregnant woman will receive the study medicine from enrollment at apporximately 28 gestation until childbirth. Each enrolled infant will receive the study medicine from birth until 6 months of age.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant women who are intending to delivery at Middlemore Hospital and who are either public patients attending the antenatal clinics at Middlemore hospital or whose lead maternity caregiver is a member of South Auckland Maternity Care Limited (SAMCL) will be invited to take part in the study during antenatal visits.
Exclusion criteria
We will exclude pregnant mothers taking vitamin D supplementation that exceeds 200 IU/day & those with a history of renal stones or hypercalcaemia or found to be hypercalcaemic at enrolment. We will also exclude any serious complication of pregnancy at the time of enrolment.
Outcome results
None listed