Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000345684
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
9/09/2005
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breast milk and Iodine Study
Scientific title
A randomised double-blind, placebo-controlled intervention trial to study the effect of iodine supplementation on breast milk iodine concentration and iodine status in lactating women and their breast-fed infants
Secondary ID [1] 287853 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine status 439 0
Condition category
Condition code
Reproductive Health and Childbirth 512 512 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Random allocation of placebo, iodine (75 micrograms/day), or iodine (150 micrograms/day) supplements to lactating women for the first six months of lactation.
Intervention code [1] 310 0
Treatment: Other
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 581 0
Breast-milk iodine concentration
Timepoint [1] 581 0
At 1, 2, 4, 8, 12, 16, 20 and 24 weeks post-partum
Secondary outcome [1] 1237 0
Iodine status of mothers and babies.
Timepoint [1] 1237 0
After six months of maternal supplementation.

Eligibility
Key inclusion criteria
Commitment to six months of breast-feeding.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No known thyroid disease. Not taking iodine containing dietary supplements. Singleton birth. Premature (<38 weeks) birth.

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)
Randomised, double-blind allocation placebo and iodine supplements (75 micrograms 150 microgram) in coded containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated by Microsoft Excel. The restriction method was a randomised block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
31/10/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
106
Recruitment outside Australia
Country [1] 154 0
New Zealand
State/province [1] 154 0
Dunedin, Otago

Funding & Sponsors
Funding source category [1] 572 0
University
Name [1] 572 0
Otago University Research Grant
Country [1] 572 0
New Zealand
Funding source category [2] 573 0
Charities/Societies/Foundations
Name [2] 573 0
Laurenson's Fund
Country [2] 573 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Dunedin, New Zealand
Address
Department of Human Nutrition
University of Otago
Dunedin, New Zealand
9054
Country
New Zealand
Secondary sponsor category [1] 464 0
None
Name [1] 464 0
None
Address [1] 464 0
Country [1] 464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1594 0
University of Otago Ethics Committee
Ethics committee address [1] 1594 0
University of Otago
Dunedin, New Zealand
9054
Ethics committee country [1] 1594 0
New Zealand
Date submitted for ethics approval [1] 1594 0
Approval date [1] 1594 0
16/03/2004
Ethics approval number [1] 1594 0

Summary
Brief summary
New Zealand has low soil iodine and the NZ diet can be low in iodine. Breastfeeding women need to get enough iodine in their diet so that they make milk with sufficient levels of iodine. This study will measure the amount of iodine in breastmilk in women who are taking a placebo (i.e. Is there enough iodine in the diet of breastfeeding NZ women now?) or iodine containing supplement (i.e. If not, will more iodine in the diet make the iodine levels in their breastmilk increase?).
Trial website
Trial related presentations / publications
Mulrine HM, Skeaff SA, Ferguson EL, Gray AM, Valeix P. Breast milk iodine concentration declines over the first six months postpartum in iodine-deficient women. American Journal of Clinical Nutrition 92;849-56 (2010)
Public notes

Contacts
Principal investigator
Name 36153 0
Dr Sheila Skeaff
Address 36153 0
Dept Human Nutrition
University of Otago
Dunedin, New Zealand
9054
Country 36153 0
New Zealand
Phone 36153 0
+643 479 7944
Fax 36153 0
Email 36153 0
[email protected]
Contact person for public queries
Name 9499 0
A/Prof Dr Sheila Skeaff
Address 9499 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 9499 0
New Zealand
Phone 9499 0
+64 3 4797944
Fax 9499 0
+64 3 4797958
Email 9499 0
[email protected]
Contact person for scientific queries
Name 427 0
A/Prof Dr Sheila Skeaff
Address 427 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 427 0
New Zealand
Phone 427 0
+64 3 4797944
Fax 427 0
+64 3 4797958
Email 427 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
SourceTitleYear of PublicationDOI
Dimensions AIBreast-milk iodine concentration declines over the first 6 mo postpartum in iodine-deficient women2010https://doi.org/10.3945/ajcn.2010.29630
N.B. These documents automatically identified may not have been verified by the study sponsor.