Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000411044
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
21/05/2010
Date last updated
13/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregnancy Iodine and Neurodevelopment in Kids (PINK)
Scientific title
A Randomised controlled trial of iodine supplementation in pregnancy to enhance neurodevelopment in children - (PINK)
Secondary ID [1] 251682 0
NA
Universal Trial Number (UTN)
Trial acronym
PINK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine Deficiency in Pregnancy 257286 0
Condition category
Condition code
Diet and Nutrition 257434 257434 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 257506 257506 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Iodine 150 ug/day, one tablet per day from enrolment to the end of pregnancy.
Intervention code [1] 256422 0
Prevention
Comparator / control treatment
Placebo contains no iodine (primary component: cellulose-microcrystalline), 1 tablet per day from enrolment to the end of pregnancy
Control group
Placebo

Outcomes
Primary outcome [1] 258357 0
Neurodevelopment of children using the Bayley Scale of Infant Development (III)
Timepoint [1] 258357 0
At 24months of age
Secondary outcome [1] 264091 0
Pregnancy outcomes via case note audit. Information on birth weight, length, head circumference and gestational age and need for intensive care of the child will be collected. Information on pregnancy-related morbidities such as stillbirth, preterm birth and pre-eclampsia, mode of delivery, maternal weight gain will also be collected.
Timepoint [1] 264091 0
At birth
Secondary outcome [2] 264118 0
Generl health & wellbeing of mothers using validated questionnaires: SF-36 & Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 264118 0
At 36weeks gestation and at 6weeks post delivery.

Eligibility
Key inclusion criteria
pregnant women <20weeks Gestation; Not taking dietary supplements containing Iodine; Free from thyroid disease; No known fetal abnormality. Able to give informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
>/=20weeks gestation. taking dietary supplements containing Iodine.

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)
Pregnant women will be approached at their first antental clinic visit at the participating centres. Eligible women who consented to take part in the study will be randomly allocated to the intervention (iodine) or placebo group. The randomisation will be done through central allocation by computer from a customised built Management Information System (MIS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratify allocation by centre, parity (0 vs >=1) and gestational age (<14 vs >=14 weeks).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
multicentre double blinded randomised controlled trial
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The NHMRC withdrew its support for a trial as a placebo controlled trial was viewed as inconsistent with its recommendation for iodine supplementation
Date of first participant enrolment
Anticipated
24/05/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
29/10/2010
Date of last data collection
Anticipated
Actual
28/02/2013
Sample size
Target
1084
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 2883 0
5006
Recruitment postcode(s) [2] 2884 0
5042
Recruitment outside Australia
Country [1] 2614 0
New Zealand
State/province [1] 2614 0
9054
Country [2] 2615 0
New Zealand
State/province [2] 2615 0
8011

Funding & Sponsors
Funding source category [1] 256909 0
Government body
Name [1] 256909 0
National Health & Medical Research Council
Country [1] 256909 0
Australia
Primary sponsor type
Hospital
Name
Children, Youth & Women's Health Service (CYWHS)
Address
72 King William Road,
North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 256182 0
Hospital
Name [1] 256182 0
Southern Adelaide Health Service
Address [1] 256182 0
Flinders Medical Centre,
Flinders Drive,
Bedford Park, SA 5042
Country [1] 256182 0
Australia
Other collaborator category [1] 1243 0
University
Name [1] 1243 0
Otago University
Address [1] 1243 0
Union Place West
Dunedin, 9054
PO Box 56
Country [1] 1243 0
New Zealand
Other collaborator category [2] 1244 0
Hospital
Name [2] 1244 0
Royal North Shore Hospital Sydney
Address [2] 1244 0
Reserve Road
ST LEONARDS NSW 2065
Country [2] 1244 0
Australia
Other collaborator category [3] 1245 0
Hospital
Name [3] 1245 0
Women's Hospital Melbourne
Address [3] 1245 0
Locked Bag 300
Grattan St & Flemington Rd
Parkville VIC 3052
Country [3] 1245 0
Australia
Other collaborator category [4] 1246 0
Hospital
Name [4] 1246 0
christchurch women's hospital
Address [4] 1246 0
2 Riccarton Ave
Christchurch 8011
Country [4] 1246 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258917 0
Children Youth & Women's Health Service Human Research Ethics Committee
Ethics committee address [1] 258917 0
72 King William Street
North Adelaide SA 5006
Ethics committee country [1] 258917 0
Australia
Date submitted for ethics approval [1] 258917 0
Approval date [1] 258917 0
15/03/2010
Ethics approval number [1] 258917 0
12/12/2230

Summary
Brief summary
Severe iodine deficiency during pregnancy is a known cause of cretinism and mental retardation. There is now growing recognition that milder iodine deficiency may also be related to cognitive deficits. Mild iodine deficiency has been consistently found in all studies of pregnant women living in Australia and New Zealand. The Australian and New Zealand governments have recently mandated the use of iodised salt in breads as a strategy to combat iodine deficiency in the general population. However, this strategy may not sufficiently increase iodine intakes to meet the requirements of pregnant women, and Food Standard Australia and New Zealand has recommended that these women take a daily dietary supplement containing 150 ug/day of iodine. However, no studies have examined the effect of iodine supplementation in pregnancy on clinical outcomes of mothers or babies in regions with mild iodine deficiency. The aims of this study are to assess the effect of maternal iodine supplementation during pregnancy at levels designed to meet the recommended dietary intake on neurodevelopment of children at 2 years of age (primary outcome), and pregnancy outcomes and general health and wellbeing of mothers. Eligible pregnant women will be randomly assigned to take either a iodine supplement (150ug/d) or placebo dairly from enrolement to the end of pregnancy. Neurodevelopment of children will be assessed using Bayley Scale of Infant and Toddler Development and maternal general health and mental function will be assessed using validated questionnaires.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31124 0
Prof Maria Makrides
Address 31124 0
SAHMRI,
PO Box 11060
Adelaide, SA 5001
Country 31124 0
Australia
Phone 31124 0
+61 8 8128 4416
Fax 31124 0
Email 31124 0
maria.makrides@sahmri.com
Contact person for public queries
Name 14371 0
Dr Dr Jo Zhou
Address 14371 0
Women's & Children's Health Research Institute (WCHRI)
Level 7 Rieger Building
Women's & Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 14371 0
Australia
Phone 14371 0
+61 8 8303 4111
Fax 14371 0
+61 8 8303 7135
Email 14371 0
jo.zhou@adelaide.edu.au
Contact person for scientific queries
Name 5299 0
Dr Dr. Jo Zhou
Address 5299 0
University of Adelaide
Waite Campus
Adelaide SA 5005
Country 5299 0
Australia
Phone 5299 0
+61 8 8303 4111
Fax 5299 0
+61 8 8303-7135
Email 5299 0
jo.zhou@adelaide.edu.au

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No Supporting Document Provided


Results publications and other study-related documents

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