Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000142235
Ethics application status
Approved
Date submitted
4/02/2009
Date registered
6/03/2009
Date last updated
1/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antenatal Vitamin D Supplementation in an at risk pregnant population (dark skinned/veiled), looking at neonatal vitamin D levels in cord blood.
Scientific title
Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial
Secondary ID [1] 288452 0
06150C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D Deficiency in at risk Pregnant women. 3995 0
Condition category
Condition code
Diet and Nutrition 4194 4194 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 4650 4650 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment arm will be given 2000 international units (IU) of cholecalciferol orally daily commencing between 14 and 18 weeks gestation. Vitamin D levels will be checked again at 28 weeks gestation. If still deficient the dose will be doubled to 4000IU orally daily until birth. Follow up will cease at six weeks postnatally but vitamin D supplements will need to be taken indefinitely.
Intervention code [1] 3720 0
Treatment: Drugs
Comparator / control treatment
No treatment during pregnancy.

The nontreatment arm will be treated after birth of the baby. The mother will recieve 300000IU cholecalciferol orally immediately and the baby 150000IU cholecalciferol orally immediately. This is known as a Stoss dose and is required only once or twice a year. Mother and baby will receive one dose during the study and will then follow up with their primary care physician. This Stoss dose needs to be given only once or twice a year at the dose recommended by a combined Australian/New Zealand working group addressing vitamin D deficiency.
Control group
Active

Outcomes
Primary outcome [1] 5090 0
Incidence of Vitmain D deficiency in a high risk population as determined by screening vitamin D blood test at recruitment.
Timepoint [1] 5090 0
At recruitment
Primary outcome [2] 5091 0
Vitamin D level >75 in neonates. As determined by cord blood assays of vitamin D at birth.
Timepoint [2] 5091 0
At birth (cord blood)
Secondary outcome [1] 8544 0
Vitamin D level >75 in women. As determined by maternal blood assays of vitamin D at birth.
Timepoint [1] 8544 0
At birth

Eligibility
Key inclusion criteria
At risk women
- dark skinned
- veiled
Anyone with vitamin D deficiency that has not commenced treatment prior to recruitment.
Minimum age
15 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women taking barbituates or anticonvulsants (decreased vitamin D absorption).
Women with severe renal failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At risk women or women with vitamin D <50 (who haven't commenced treatment) are recruited at their first visit to our antenatal clinic. If levels are confirmed <50 they are randomised using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
result of coin toss then placed in envelopes in a tamper proof box
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
8/04/2008
Date of last participant enrolment
Anticipated
Actual
17/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 12685 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 4192 0
Other Collaborative groups
Name [1] 4192 0
Royal Australian and New Zealand College of Obstetrics and Gynaecology
Country [1] 4192 0
Australia
Primary sponsor type
Individual
Name
Jodie Benson
Address
C/O
Womens and Childrens Services
University Hospital Geelong
PO Box 281
Geelong 3220
Country
Australia
Secondary sponsor category [1] 3766 0
Individual
Name [1] 3766 0
A Prof Beverley Vollenhoven
Address [1] 3766 0
c/o Monash Medical Centre
Clayton Rd
Clayton
Victoria 3168
Country [1] 3766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6249 0
Southern Health Human Research and Ethics Committee
Ethics committee address [1] 6249 0
C/O Monash Medical Centre
Clayton Rd
Clayton
Victoria 3168
Ethics committee country [1] 6249 0
Australia
Date submitted for ethics approval [1] 6249 0
19/10/2006
Approval date [1] 6249 0
27/08/2007
Ethics approval number [1] 6249 0
06150C

Summary
Brief summary
The incidence of childhood rickets is increasing and is caused by vitamin D deficiency. Of those children, 81% of their mothers are also deficient.

We aim to screen high risk women in early pregnancy and randomise those found deficient to either treatment with vitamin D supplements or non-treatment. We will monitor the effect of vitamin D supplementation by repeating vitamin D concentrations during pregnancy, cord and maternal blood at birth, and infant and maternal blood at six weeks postnatally.

We hope to develop a protocol so all high risk women will be identified and treated, thereby preventing paediatric complications.
Trial website
Trial related presentations / publications
Rodda CP, Benson JE, Vincent AJ, Whitehead CL, Polykov A, Vollenhoven B. Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial.
Clin Endocrinol (Oxf). 2015 Sep;83(3):363-8. doi: 10.1111/cen.12762. Epub 2015 Apr 8.
Public notes

Contacts
Principal investigator
Name 29144 0
A/Prof Christine Rodda
Address 29144 0
Depatrment of Paediatrics
The University of Melbourne
Parkville
3052
Country 29144 0
Australia
Phone 29144 0
61383958161
Fax 29144 0
Email 29144 0
[email protected]
Contact person for public queries
Name 12301 0
Dr Jodie Benson
Address 12301 0
CO/ University Hospital Geelong
PO Box 281
Geelong
3220
Country 12301 0
Australia
Phone 12301 0
61342150000
Fax 12301 0
Email 12301 0
[email protected]
Contact person for scientific queries
Name 3229 0
Dr Jodie Benson
Address 3229 0
CO/
University Hospital Geelong
PO Box 281
Geelong
3220
Country 3229 0
Australia
Phone 3229 0
61342150000
Fax 3229 0
Email 3229 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.