Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001145897
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
30/10/2012
Date last updated
30/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Vitamin D supplementation in pregnancy improve maternal glucose metabolism or prevent gestational diabetes?
Scientific title
Effect of high-dose versus low-dose vitamin D supplementation in pregnancy on maternal glucose metabolism and the risk of gestational diabetes.
Secondary ID [1] 281424 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 237276 0
Pregnancy 287675 0
Condition category
Condition code
Metabolic and Endocrine 239599 239599 0 0
Normal metabolism and endocrine development and function
Reproductive Health and Childbirth 288058 288058 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women will be randomly allocated to take high-dose vitamin D supplementation (5000IU/day) or standard dose pregnancy vitamin supplementation (400 IU vitamin D daily), administered as an oral capsule, from the time of the first antenatal clinic visit (around 12 weeks gestation) until delivery.
Intervention code [1] 236959 0
Treatment: Drugs
Intervention code [2] 285966 0
Prevention
Comparator / control treatment
Standard dose vitamin D supplementation (as in commonly used pregnancy multivitamin preparations)
Control group
Dose comparison

Outcomes
Primary outcome [1] 238392 0
Maternal glucose metabolism in late second trimester (26-28 weeks gestation) assessed by glucose tolerance test (blood analysis after ingestion of 75g oral glucose).
Timepoint [1] 238392 0
26-28 weeks gestation
Primary outcome [2] 238393 0
Diagnosis of Gestational Diabetes, determined by an oral Glucose Tolerance Test (blood analysis after ingestion of 75g oral glucose) performed at 26-28 weeks gestation, or other evidence of hyperglycaemia recorded throughout pregnancy.
Timepoint [2] 238393 0
End of pregnancy
Secondary outcome [1] 244854 0
Infant weight at birth, infant length (assessed with a newborn stadiometer) and head circumference.
Timepoint [1] 244854 0
First week of life

Eligibility
Key inclusion criteria
Pregnancy, less than 20 weeks gestation at recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known diabetes
Calcium metabolic disorder
Multiple pregnancy

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)
Patients will be recruited at their first antenatal clinic visit. Baseline tests will exclude pre-existing diabetes, hypercalcaemia or vitamin D toxicity. Treatment will be stratified according to baseline serum vitamin D levels and randomized by the trial pharmecist using opaque envelopes containing a treatment allocation. Patient, treating clinician and researchers will remain blinded to treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Opaque envelopes containing treatment allocation to one of 2 dose levels of Vitamin D (identical capsules). Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1940 0
2145

Funding & Sponsors
Funding source category [1] 237344 0
Hospital
Name [1] 237344 0
Westmead Hospital
Country [1] 237344 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 236835 0
University
Name [1] 236835 0
University of Western Sydney
Address [1] 236835 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 2751
Country [1] 236835 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239464 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 239464 0
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [1] 239464 0
Australia
Date submitted for ethics approval [1] 239464 0
Approval date [1] 239464 0
07/10/2009
Ethics approval number [1] 239464 0
AU RED HREC/09/WMEAD/54 HREC2009/4/4.1 (2953)

Summary
Brief summary
This study will determine whether taking additional Vitamin D supplementation in pregnancy, above that contained in conventional pregnancy vitamin tablets, improves a woman's glucose metabolism and prevents the development of gestational diabetes, a common complication of pregnancy in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29915 0
Address 29915 0
Country 29915 0
Phone 29915 0
Fax 29915 0
Email 29915 0
Contact person for public queries
Name 13162 0
Mark McLean
Address 13162 0
Professor Mark McLean
University of Western Sydney - Blacktown Clinical School
Blacktown Hospital
PO Box 6105 BLACKTOWN NSW 2148
Country 13162 0
Australia
Phone 13162 0
+61 2 9851 6073
Fax 13162 0
+61 2 9851 6050
Email 13162 0
m.mclean@uws.edu.au
Contact person for scientific queries
Name 4090 0
Mark McLean
Address 4090 0
Professor Mark McLean
University of Western Sydney - Blacktown Clinical School
Blacktown Hospital
PO Box 6105 BLACKTOWN NSW 2148
Country 4090 0
Australia
Phone 4090 0
+61 2 9851 6073
Fax 4090 0
+61 2 9851 6050
Email 4090 0
m.mclean@uws.edu.au

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

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