Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001044011
Ethics application status
Not yet submitted
Date submitted
23/11/2010
Date registered
29/11/2010
Date last updated
29/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D deficiency in Pregnancy - A comparison of two treatments
Scientific title
A randomised double blinded interventional trial to determine the effect of 50,000 IU vitamin D supplementation monthly or twice monthly from 20 weeks gestation.
Secondary ID [1] 253143 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency in pregnancy 258695 0
Condition category
Condition code
Metabolic and Endocrine 258845 258845 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women in trial will be randomly allocated to recieve either 50000IU vitamin D oral tablet supplementation monthly or twice monthly from 20 weeks gestation until birth of baby.
Intervention code [1] 257651 0
Treatment: Other
Comparator / control treatment
There are two arms in the study. One arm of the study will received 50000 IU tablets twice monthly, 2 weeks apart. The other arm of the study will receive 50000IU monthly and a placebo monthly, 2 weeks apart from 20 weeks gestation until delivery of baby. The placebo tablet contains lactose monohydrate, acacia, calcium carbonate, castor oil, maize starch, povidone, sucrose, purified talc, hydrated silica, powdered cellulose, magnesium sterate, shellac, gelatin, beeswax white, titanium dioxide and prepared theobroma.
Control group
Dose comparison

Outcomes
Primary outcome [1] 259701 0
Cord blood samples will be taken at delivery. If emergencies at delivery prevent a cord blood sample being taken then a maternal venous blood sample will be taken for analysis. The blood will be stored as per Capital and Coast laboratory protocols and will be analysed in batches to limit between test variation.
Timepoint [1] 259701 0
At delivery of newborn
Secondary outcome [1] 266412 0
To determine the vitamin D supplementation required to ensure vitamin D repletion at delivery, and by proxy for newborns to begin life with adequate vitamin D stores. T-tests will be carried out to compare the mean improvement in serum vitamin D levels between the two different treatment doses
Timepoint [1] 266412 0
At delivery of newborn

Eligibility
Key inclusion criteria
Pregnant women seeking maternity care with midwifery services involved in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If antenatal Vitamin D level is > 75nmol/litre when enrolling in study

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)
All women seeking maternity care with Newtown Union Health and Nga Tapuhiwhakawhanau midwifery services will be invited to enrol in study and will have their vitamin D levels measured by 16 weeks gestation. Those with vitamin D <75nmol/l will be randomly and blindly allocated to receive 50,000IU monthly or twice monthly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
When a woman's blood test results are received and eligible for the trial, they will be allocated in a predetermined and random manner by serially tossing of a coin. Allocation is not concealed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3062 0
New Zealand
State/province [1] 3062 0

Funding & Sponsors
Funding source category [1] 258118 0
Other Collaborative groups
Name [1] 258118 0
Royal New Zealand College of GP's
Country [1] 258118 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Newtown Union Health Service
Address
14 Hall Ave
Newtown
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 257296 0
Charities/Societies/Foundations
Name [1] 257296 0
Wellington Medical Research Foundation
Address [1] 257296 0
PO Box 51 211
Wellington
6011
New Zealand
Country [1] 257296 0
New Zealand
Other collaborator category [1] 251673 0
Individual
Name [1] 251673 0
Dr Jeremy Krebs
Address [1] 251673 0
Endocrinologist
Capital and Coast Health
Riddiford Street
Wellington
6021
Country [1] 251673 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260101 0
Central Ethics Committee
Ethics committee address [1] 260101 0
Level 1
1 The Terrace
Wellington
6011
Ethics committee country [1] 260101 0
New Zealand
Date submitted for ethics approval [1] 260101 0
30/11/2010
Approval date [1] 260101 0
Ethics approval number [1] 260101 0

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

Contacts
Principal investigator
Name 31943 0
Address 31943 0
Country 31943 0
Phone 31943 0
Fax 31943 0
Email 31943 0
Contact person for public queries
Name 15190 0
Dr Annie Judkins
Address 15190 0
Newtown Union Health Service
14 Hall Ave
Newtown
Wellington
6021
Country 15190 0
New Zealand
Phone 15190 0
644 3802020
Fax 15190 0
Email 15190 0
annie.judkins@nuhs.org.nz
Contact person for scientific queries
Name 6118 0
Dr Jeremy Krebs
Address 6118 0
Capital and Coast Health
Riddiford Street
Newtown
Wellington
6021
Country 6118 0
New Zealand
Phone 6118 0
644 3855999
Fax 6118 0
Email 6118 0
jeremy.krebs@ccdhb.org.nz

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.