Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000241831
Ethics application status
Approved
Date submitted
23/02/2012
Date registered
24/02/2012
Date last updated
27/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary intake of micronutrients during pregnancy and breastfeeding after government initiatives to increase iodine intake
Scientific title
Micronutrient intakes and status in pregnant and breastfeeding women after government initiatives to increase iodine intake
Secondary ID [1] 280021 0
Nil
Universal Trial Number (UTN)
U1111-1128-3967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine intake and status during pregnancy and lactation 285929 0
Selenium intake and status during pregnancy and lactation 285930 0
Dietary intake of other nutrients during pregnancy and lactation 285931 0
Condition category
Condition code
Diet and Nutrition 286120 286120 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 286121 286121 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There have been two government initiatives to improve iodine intake and status. These are the mandatory fortification of bread with iodised salt and the provision of a subsidised iodine supplement for all pregnant and lactating women. This study will investigate how much fortified bread women habitually consume, the uptake of the subsidised supplement and the effect of both on iodine intake and status. This is an observational study investigating the behaviour of free living indiviuals no intervention will be given. Recruitment will last 6 months
Intervention code [1] 284341 0
Not applicable
Comparator / control treatment
Iodine and selenium intakes in pregnant and breastfeeding women in previous New Zealand studies from 1990 to 2009. Also previous study by researchers http://www.ANZCTR.org.au/ACTRN12612000240842.aspx
Control group
Historical

Outcomes
Primary outcome [1] 286594 0
Iodine and selenium concentrations measured in samples of urine collected over 24 hours
Timepoint [1] 286594 0
Pregnant women of gestational age greater than 26 weeks and lactating women at least 3 weeks postpartum
Secondary outcome [1] 296230 0
Iodine and selenium concentrations measured in samples of breastmilk
Timepoint [1] 296230 0
Lactating women at least 3 weeks postpartum
Secondary outcome [2] 296231 0
Dietary intake of other nutrients assessed using three 24 hour diet histories and dietary assessment computer package (Foodworks 2009)
Timepoint [2] 296231 0
Pregnant women of gestational age greater than 26 weeks and lactating women at least 3 weeks postpartum

Eligibility
Key inclusion criteria
Healthy pregnant women > 26 weeks gestation
Healthy breastfeeding women > 3 weeks postpartum
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No medical complications
No complications during pregnancy or breastfeeding
No medications containing iodine or selenium

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4170 0
New Zealand
State/province [1] 4170 0

Funding & Sponsors
Funding source category [1] 284775 0
University
Name [1] 284775 0
Massey University Research Fund
Country [1] 284775 0
New Zealand
Funding source category [2] 284776 0
Charities/Societies/Foundations
Name [2] 284776 0
Palmerston North Medical Research Foundation
Country [2] 284776 0
New Zealand
Primary sponsor type
Individual
Name
Louise Brough
Address
Massey University
Private Bag 11 222
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 283664 0
University
Name [1] 283664 0
Massey University
Address [1] 283664 0
Massey University
Private Bag 11 222
Palmerston North
4442
Country [1] 283664 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286768 0
Massey University Human Ethics Committee Southern A
Ethics committee address [1] 286768 0
Massey University
Private Bag 11 222
Palmerston North
4442
Ethics committee country [1] 286768 0
New Zealand
Date submitted for ethics approval [1] 286768 0
Approval date [1] 286768 0
26/08/2010
Ethics approval number [1] 286768 0
10/54

Summary
Brief summary
Iodine and selenium intakes are known to be low in New Zealand. Two government initaitives have been introduced to improve intake among pregnant and lactating women. This study will investigate the effect of these initiatives on iodine intake and status. Selenium intake and status and the intake of other nutrients will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33828 0
Address 33828 0
Country 33828 0
Phone 33828 0
Fax 33828 0
Email 33828 0
Contact person for public queries
Name 17075 0
Louise Brough
Address 17075 0
Massey University
Private Bag 11 222
Palmerston North
4442
Country 17075 0
New Zealand
Phone 17075 0
0064 6 356 9099 ext 7732
Fax 17075 0
Email 17075 0
[email protected]
Contact person for scientific queries
Name 8003 0
Louise Brough
Address 8003 0
Massey University
Private Bag 11 222
Palmerston North
4442
Country 8003 0
New Zealand
Phone 8003 0
0064 6 356 9099 ext 7732
Fax 8003 0
Email 8003 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.