Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000240842
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
Scientific title
Micronutrient intake and status in pregnant and breastfeeding women
Secondary ID [1] 279991 0
Nil
Universal Trial Number (UTN)
U1111-1128-3267
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine deficiency during pregnancy and lactation 285899 0
Selenium deficiency during pregnancy and lactation 285900 0
Condition category
Condition code
Diet and Nutrition 286090 286090 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 286091 286091 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
Iodine and selenium intake and status estimated in pregnant and breastfeeding women in NZ. Participants will supply one sample of urine collected over 24 hours. Breastfeeding women will also supply one sample of breastmilk. Recruitment will last 6 months.
Intervention code [1] 284317 0
Not applicable
Comparator / control treatment
Iodine and selenium intakes in pregnant and breastfeeding women in previous NZ studies from 1990-2009 reported in journal articles.
Control group
Historical

Outcomes
Primary outcome [1] 286593 0
Iodine and selenium concentrations measured in a 24 hour urine sample. Each participant will collect all the urine excreted over one 24 hour period.
Timepoint [1] 286593 0
Pregnant women of gestational age greater than 26 weeks and lactating women at least 3 weeks postpartum
Secondary outcome [1] 296228 0
Iodine and selenium concentrations measured in breast milk
Timepoint [1] 296228 0
Lactating women at least 3 weeks postpartum. Each participant will provide 1 sample of breastmilk (around 30 ml).
Secondary outcome [2] 296229 0
Dietary intake of other nutrients assessed using three 24 hour diet histories and dietary assessment computer package (Foodworks 2009)
Timepoint [2] 296229 0
Pregnant women of gestational age greater than 26 weeks and lactating women at least 3 weeks postpartum. 24 hour diet recalls will be collected at the first interview and then 2 further consecutive weeks.

Eligibility
Key inclusion criteria
Healthy pregnant women > 26 weeks gestational age
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 lactation
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
1/12/2008
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] 4154 0
New Zealand
State/province [1] 4154 0

Funding & Sponsors
Funding source category [1] 284773 0
University
Name [1] 284773 0
Massey University Research Fund
Country [1] 284773 0
New Zealand
Primary sponsor type
Individual
Name
Louise Brough
Address
Massey University Manawatu
Private Bag 11 222
Palmerston North
4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 283663 0
University
Name [1] 283663 0
Massey University
Address [1] 283663 0
Massey University Manawatu
Private Bag 11 222
Palmerston North
4442
New Zealand
Country [1] 283663 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286774 0
Massey University Ethics Committee Southern A
Ethics committee address [1] 286774 0
Massey University Manawatu
Private Bag 11 222
Palmerston North
4442
Ethics committee country [1] 286774 0
New Zealand
Date submitted for ethics approval [1] 286774 0
Approval date [1] 286774 0
22/08/2008
Ethics approval number [1] 286774 0
08/32

Summary
Brief summary
Iodine and selenium intakes are known to be low in New Zealand. The study will investigate current iodine and selenium intakes in a North Island population of pregnant and breastfeeding women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33810 0
Address 33810 0
Country 33810 0
Phone 33810 0
Fax 33810 0
Email 33810 0
Contact person for public queries
Name 17057 0
Louise Brough
Address 17057 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 11 222
Palmerston North 4442
Country 17057 0
New Zealand
Phone 17057 0
0064 6 356 9099 ext 7732
Fax 17057 0
Email 17057 0
[email protected]
Contact person for scientific queries
Name 7985 0
Louise Brough
Address 7985 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 11 222
Palmerston North 4442
Country 7985 0
New Zealand
Phone 7985 0
0064 6 356 9099 ext 7732
Fax 7985 0
Email 7985 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.