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Pregnancy Iodine and Neurodevelopment in Kids (PINK)

A Randomised controlled trial of iodine supplementation in pregnancy to enhance neurodevelopment in children - (PINK)

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000411044
Acronym
PINK
Enrollment
59
Registered
2010-05-21
Start date
2010-06-01
Completion date
2010-10-29
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Iodine 150 ug/day, one tablet per day from enrolment to the end of pregnancy.

Sponsors

Children, Youth & Women's Health Service (CYWHS)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

>/=20weeks gestation. taking dietary supplements containing Iodine.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026