Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000483055
Ethics application status
Approved
Date submitted
2/02/2010
Date registered
1/04/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 1393 0
None
Universal Trial Number (UTN)
U1111-1113-5351
Trial acronym
PIVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 256728 0
Condition category
Condition code
Diet and Nutrition 256883 256883 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 256945 256945 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255950 0
Prevention
Intervention code [2] 256002 0
Treatment: Other
Comparator / control treatment
The placebo is a thin vegetable oil (purified components of coconut and palm oil). the placebo is given in the same dose and for the same duration and the study medicine, i.e. one drop per day for pregnant mothers from enrollment until childbirth and one drop per day for each infant from birth until 6 months of age
Control group
Placebo

Outcomes
Primary outcome [1] 257759 0
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.
Timepoint [1] 257759 0
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.
Primary outcome [2] 257760 0
The number of mothers and infants with hypercalcaemia at any measurement point.
Timepoint [2] 257760 0
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 [1] 263145 0
The secondary outcome is the proportion of mothers achieving a serum 25[OH]vitamin D concentration > 75 nmol/L at 36 weeks gestation.
Timepoint [1] 263145 0
36 weeks gestation

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment outside Australia
Country [1] 2336 0
New Zealand
State/province [1] 2336 0

Funding & Sponsors
Funding source category [1] 256452 0
Government body
Name [1] 256452 0
Health Research Council of New Zealand
Country [1] 256452 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 255760 0
University
Name [1] 255760 0
University of Otago
Address [1] 255760 0
School of Medicine & Health Sciences University of Otago, Wellington
PO Box 7343, Wellington South,
Wellington 6242
Country [1] 255760 0
New Zealand
Other collaborator category [1] 1107 0
Hospital
Name [1] 1107 0
Middlemore and Kidz First Hospital
Address [1] 1107 0
Counties Manukau District Health Board
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [1] 1107 0
New Zealand
Other collaborator category [2] 1108 0
University
Name [2] 1108 0
Harvard University
Address [2] 1108 0
Associate Professor Carlos Camargo
Massachusetts General Hospital;
Harvard Medical School
326 Cambridge St, Suite 410
Boston, MA 02114 USA
Country [2] 1108 0
United States of America
Other collaborator category [3] 1109 0
University
Name [3] 1109 0
Harvard University
Address [3] 1109 0
Professor Scott Weiss
Harvard Medical School
Brigham & Womens Hospital
181 Longwood Avenue
Boston, MA 02115
Country [3] 1109 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258505 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258505 0
Ethics committee country [1] 258505 0
New Zealand
Date submitted for ethics approval [1] 258505 0
Approval date [1] 258505 0
21/12/2009
Ethics approval number [1] 258505 0
NTX/09/11/101

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30521 0
Address 30521 0
Country 30521 0
Phone 30521 0
Fax 30521 0
Email 30521 0
Contact person for public queries
Name 13768 0
Associate Professor Cameron Grant
Address 13768 0
Department of Paediatrics
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 13768 0
New Zealand
Phone 13768 0
64 9 373 7999
Fax 13768 0
64 9 373 7486
Email 13768 0
[email protected]
Contact person for scientific queries
Name 4696 0
Associate Professor Cameron Grant
Address 4696 0
Department of Paediatrics
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 4696 0
New Zealand
Phone 4696 0
64 9 373 7999
Fax 4696 0
64 9 373 7486
Email 4696 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIVitamin D During Pregnancy and Infancy and Infant Serum 25-Hydroxyvitamin D Concentration2014https://doi.org/10.1542/peds.2013-2602
EmbaseVitamin D activity of breast milk in women randomly assigned to Vitamin D3 supplementation during pregnancy.2016https://dx.doi.org/10.3945/ajcn.115.114603
EmbaseVitamin D supplementation during pregnancy and infancy reduces aeroallergen sensitization: a randomized controlled trial.2016https://dx.doi.org/10.1111/all.12909
EmbaseWe are still confused but on a higher level.2019https://dx.doi.org/10.1111/all.13819
N.B. These documents automatically identified may not have been verified by the study sponsor.