The Effect of Iodine Intakes on Maternal and Infant Health and the Study of Iodine RNI for Different Stages of Pregnancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Thyroid goiter confirmed by ultrasonographic thyroid volume
研究概览
简要总结
This study determined the effects of different iodine intake on the maternal and infant health and provide evidence for studying the RNI and UL of iodine in pregnant women.
- The study of effect on mothers and their infants of the lack of iodine at different gestation in adequate iodine area.
The purpose of this study was to detect the maternal thyroid function, growth and neuropsychological development of infants in different pregnancy women with diverse iodine intake levels, and to make a clear evaluation for the influence of iodine deficiency during different pregnancy by following up iodine suitable early pregnancy women and mild iodine deficient three pregnancy women as well as their infants. 2. The study of recommended iodine intake (RNI) for healthy pregnant women in three pregnancy.
Different pregnancy women with different iodine intake levels were recruited and carried out iodine balance experiment in the case of not interfering with their diet. In addition, the iodine intake of the pregnant women when they reached "zero iodine balance" was calculated, that was EAR of iodine in pregnant women. In conclusion, the iodine balance experiment in pregnant women at different pregnancy improved the sample collection methods and evaluation criteria and was more scientific and reasonable than the classic iodine balance experiment. 3. The study of effect of different levels of high iodine exposure on pregnant women, delivery women and their infants.
In this study, we made a prospective study of the early pregnancy women and their infants exposed to different high iodine levels in high water iodine areas. At first we defined the effects of long-term iodine excess exposure on the health of the mother and the infants by combining with the reference index of the normal value of the thyroid function in different maternal and postpartum periods, the level of growth and development of the offspring and the assessment of the level of neuropsychological development. Furthermore the harmful effects of different high levels of iodine exposure on pregnant women was synthetically analyzed. This study obtained the safe intake level of iodine for pregnant women and provided scientific basis for the formulation of iodine UL in pregnant women in China.
详细描述
-
The relationship between iodine deficiency during pregnancy and maternal offspring health
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Screening of pregnant women with iodine deficiency:
A prevalence survey of pregnant women was conducted in iodine-sufficient area, combined with the results of single spot urinary concentration, 24h urinary iodine concentration and thyroglobulin level, screening out pregnant women with iodine deficiency during first, second and third trimester of pregnancy. There are 60 pregnant women in each group. At the same time, 60 pregnant women with iodine-sufficient during early pregnancy were selected, and the total number of the four groups is 240. 2. Effects of iodine deficiency on pregnant women during different pregnancy:
Pregnant women with iodine deficiency were gived nutritional guidance, and were advised to take iodine supplements. Follow-up with regularly collecting fasting venous blood, dried whole blood and single spot urine was conducted, in order to dynamically grasp the iodine nutritional status and thyroid function of pregnant women during different pregnancy, and clarify the influence of iodine deficiency on pregnant women in each group. 3. Effects of iodine deficiency on offspring during different pregnancy:
The offspring of follow-up pregnant women were observed, collecting the heel blood at birth for measuring TSH, and performing physical examination. Assessment of neuropsychological development in offspring for two years after delivery was performed , in order to clarify the effects of iodine deficiency on the neuropsychological development of offspring in each group. 4. Statistical analysis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 18-35 years old; 2) singleton pregnancy; 3) Living in Tianjin or Shandong at least 5 years; 4) no history of any thyroid diseases; 5) no medication or supplementation of iodine.
排除标准
- 未提供
结局指标
主要结局
Thyroid goiter confirmed by ultrasonographic thyroid volume
时间窗: 3 years
Thyroid lobe volume was calculated according to the following formula: V (mL)=0.479×d×w×l (mm)/1000, and TV was records as the sum of both lobes.
Iodine intake were measured by Iodine balance experiment
时间窗: 1 years
24h iodine intake =24h dietary iodine intake + 24h water iodine intake + 24h respiratory iodine intake
Thyroid dysfunction confirmed by serum concentrations of FT3, FT4, TSH ,TPOAB and TGAb
时间窗: 3 years
Thyroid function is not in the normal reference range and is defined as thyroid dysfunction
Evaluation of neuropsychological development of children at age 2
时间窗: 2 years
Children were tested by the neurodevelopmental scale compiled by the Capital Institute of Pediatrics.In this experiment, DQ (\> 130) was classified as excellent, 115-129 as upper, 85-114 as middle, 70-84 as lower, and (\< 69) as mental retardation.
次要结局
未报告次要终点
研究者
Wanqi Zhang
Vice Dean for School of Public Health
Tianjin Medical University