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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
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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.
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Secondary ID [1]
253143
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency in pregnancy
258695
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Condition category
Condition code
Metabolic and Endocrine
258845
258845
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
257651
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Treatment: Other
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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.
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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At delivery of newborn
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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At delivery of newborn
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Eligibility
Key inclusion criteria
Pregnant women seeking maternity care with midwifery services involved in the study.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
If antenatal Vitamin D level is > 75nmol/litre when enrolling in study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3062
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New Zealand
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State/province [1]
3062
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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Royal New Zealand College of GP's
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Address [1]
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Level 3
88 The Terrace
Wellington
6011
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Country [1]
258118
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New Zealand
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Primary sponsor type
Charities/Societies/Foundations
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Name
Newtown Union Health Service
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Address
14 Hall Ave
Newtown
Wellington
6021
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Country
New Zealand
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Secondary sponsor category [1]
257296
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Charities/Societies/Foundations
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Name [1]
257296
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Wellington Medical Research Foundation
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Address [1]
257296
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PO Box 51 211
Wellington
6011
New Zealand
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Country [1]
257296
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New Zealand
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Other collaborator category [1]
251673
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Individual
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Name [1]
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Dr Jeremy Krebs
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Address [1]
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Endocrinologist
Capital and Coast Health
Riddiford Street
Wellington
6021
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Country [1]
251673
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
260101
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Central Ethics Committee
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Ethics committee address [1]
260101
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Level 1
1 The Terrace
Wellington
6011
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Ethics committee country [1]
260101
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New Zealand
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Date submitted for ethics approval [1]
260101
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30/11/2010
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Approval date [1]
260101
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Ethics approval number [1]
260101
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31943
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Annie Judkins
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Address
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Newtown Union Health Service
14 Hall Ave
Newtown
Wellington
6021
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Country
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New Zealand
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Phone
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644 3802020
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jeremy Krebs
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Address
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Capital and Coast Health
Riddiford Street
Newtown
Wellington
6021
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Country
6118
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New Zealand
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Phone
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644 3855999
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Fax
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Email
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[email protected]
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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.
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