Randomised placebo controlled study of vitamin D during pregnancy and infancy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000483055
• Date of registration: 01/04/2010
• Prospective Registration: Yes
• Primary sponsor: University of Auckland
• Public title: Randomised placebo controlled study of vitamin D during pregnancy and infancy
• Scientific title: Randomised placebo controlled study of vitamin D3 during pregnancy and infancy to determine the vitamin D dose in pregnancy and early life that safely and effectively increases serum vitamin D concentration in infants.
• Date of first enrolment: 01/04/2010
• Target sample size: 260
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12610000483055.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Phase 2

Countries of recruitment

New Zealand

Contacts

• Name: Associate Professor Cameron Grant

• Name: Associate Professor Cameron Grant

Key inclusion & exclusion criteria

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.

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Normal pregnancy

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;
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

Diet and Nutrition - Other diet and nutrition disorders

Intervention(s)

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.

Primary Outcome(s)

The primary outcome measure is the proportion of infants achieving a serum 25[OH]vitamin D concentration > 75 nmol/L at 6 months of age.[Each enrolled pregnant woman will have 2 blood samples obtained for measurement of 25[OH]vitamin D concentration. The first will be at booking (approx. 28 weeks) and the second at approx. 36 weeks gestation. 25[OH]vitamin D concentration will be measured on an umbilical cord blood sample collected at birth. 25[OH]vitamin D concentration will be measured on blood samples collected from the infant at 2 months, 4 months and 6 months of age.]

The number of mothers and infants with hypercalcaemia at any measurement point.[Each enrolled pregnant woman will have 2 blood samples obtained for measurement of serum calcium concentration. The first will be at booking (approx. 28 weeks) and the second at approx 36 weeks gestation. Serum calcium concentration will be measured on an umbilical cord blood sample collected at birth. Serum calcium concentration will be measured on blood samples collected from the infant at 2 months, 4 months and 6 months of age.]

Secondary Outcome(s)

The secondary outcome is the proportion of mothers achieving a serum 25[OH]vitamin D concentration > 75 nmol/L at 36 weeks gestation.[36 weeks gestation]

Secondary ID(s)

None

Source(s) of Monetary Support

Health Research Council of New Zealand

Secondary Sponsor(s)

University of Otago

Ethics review

Status: Approved
Approval date:
Contact:

Northern X Regional Ethics Committee