Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 794
- 试验地点
- 2
- 主要终点
- Infant Developmental quotient (DQ)
研究概览
简要总结
A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (>165 μg/d from food alone) on cognitive development of children at 24 months of age.
详细描述
It is known that severe iodine deficiency during pregnancy leads to profound intellectual disabilities in the child. Following results of a 2004 national survey of school-aged children showing that mild iodine deficiency had re-emerged in the south-eastern parts of Australia, the Australian government mandated the addition of iodine to salt used in bread making to increase population iodine intake. It is also recommended that all pregnant and lactating women take an additional iodine supplement containing 150 µg/d of iodine.
Since this time, further evidence has emerged from cohort studies that children born to women with high iodine intake (as well as low iodine intake) have poorer neurodevelopmental scores, suggesting that more tailored supplementation may be a better strategy. Our PoppiE trial will determine if limiting iodine supplementation in women who already consume adequate iodine from food, improves cognitive scores in early childhood.
A total of 754 pregnant women from around Australia who are ≤13 weeks of gestation will be enrolled and randomised to receive a standard prenatal vitamin and mineral supplement with a reduced amount of iodine (20 μg - intervention) or a standard prenatal vitamin and mineral supplement with 200 μg of iodine (control). The control supplement contains a level of iodine to match the amount in most commonly used vitamin and mineral supplements sold in Australia. Infant neurodevelopment at 24 months of age will be assessed using the Bayley-IV and conducted at participating centres or a location convenient to the family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Intervention and Control supplements will be packaged by Factors Group of Companies and labelled by contracted pharmaceutical personnel who are not involved in the trial. Study supplement bottles will be identified only by the blinded Product ID to match the randomisation schedule prepared by an independent statistician.
Research Personnel will access the Randomisation Module in REDCap and women will be allocated a random, unique, re-identifiable randomisation ID. Women will be issued with supplements labelled to match their unique assigned code.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women ≤13 weeks of gestation.
- •Consume greater than 165 µg/d of iodine from food alone based on our validated Iodine Specific Food Frequency Questionnaire (I-FFQ).
- •English is main language spoken at home as child will need to understand and take instruction in English to participate in the neurodevelopmental assessment.
- •Able to give informed consent.
排除标准
- •Known history of thyroid disease.
- •Previous child diagnosed with thyroid dysfunction.
- •Carrying a fetus with a known or suspected congenital abnormality.
结局指标
主要结局
Infant Developmental quotient (DQ)
时间窗: 24 months of age
The Bayley Scales of Infant and Toddler Development, 4th Edition Cognitive Scale score has a mean of 100 and standard deviation of 15, where higher scores indicate a better outcome. As the Bayley scales are age-standardized scales the exact minimum and maximum score depends on the exact age of the child at the time of the assessment, hence we have instead provided the mean and standard deviation (as is the norm when reporting standardized psychometric assessments).
次要结局
- Language development of infants using Bayley-IV(24 months of age)
- Behavioral and emotional development(24 months of age)
- Health service utilization(24 months of age)
- Length of gestation(Birth)
- Infant Birth Anthropometrics(Birth)
- Admission to special care baby unit (level 2 nursery).(The neonatal period including birth to 28 days of age)
- Thyroid stimulating hormone (TSH) level(Within 5 days of birth)
- Motor development of infants(24 months of age)
- Infant Anthropometrics(24 months of age)
研究者
Karen Best
Senior Research Fellow
South Australian Health and Medical Research Institute