Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Thyroid volume
研究概览
简要总结
Due to the lack of direct evidence of optimal iodine intake of Chinese children, pregnant and lactating women and infants were found during the recent revision of Chinese dietary reference intakes (DRIs) of iodine in 2013 by the applicant Pro. Zhang, and no systematical research about compensatory mechanism of iodine nutrition in lactating women was found yet. Previous study funded by United Nations International Children's Emergency Fund (UNICEF) cooperated with the international experts on iodine and key project of national natural science foundation of China under the guidance of Pro. Zhang, had obtained the safe intake range of iodine from children and pregnant women, more than 10 joint papers were published, which laid the foundation of population study and international cooperation.
详细描述
Studies indicate lactating women and their infants are the most vulnerable population to the adverse effects of iodine deficiency and excess, and because of the complexity of the study of lactating mothers and infants and the difficulty of sample collection, it is proposed to overcome this problem with the help of the advanced dried blood spot technique and iodine balance study method from the panel of Iodine Global Network (IGN). Investigators intend to recruit 900 late pregnant women in Tianjin, Hebei and Shandong;then establishing a dynamic cohort of breastfeeding mother-infant to 6 months after delivery to investigate the physiological compensatory mechanism of iodine nutrition in lactating women with the combination of animal experiment; On the other hand, 180 exclusively breastfeeding mother and infants within postpartum 0-6 months, will be selected to participate the iodine balance study.
Optimized method of iodine balance experiment of infants by both foreign partner and Pro. Zhang's team will be adopted to obtain the first iodine balance value of Chinese lactating women and infants,providing the direct evidence for the revision of DRIs in lactating women and infants, and guide the lactating women proper iodine supplementation to meet the requirements of both mothers and infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Day 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women in their third trimester:⑴Aged 18-40, who have lived in the area for 1 year;⑵Single pregnancy;⑶Those who have no special dietary habits;
- •Lactating woman:⑴Breastfeeding a child;⑵Normal thyroid function during pregnancy;⑶Term delivery (38-42 weeks of gestation);
- •Infants and young children:⑴0-6 months;⑵Breastfeeding;⑶Full term (38-42 weeks of gestation);⑷Normal birth weight (2500-4000g);⑸The thyroid-stimulating hormone (TSH) value of heel blood was normal;⑹Apgar score 8.
排除标准
- •Women in their third trimester:⑴Smoking or drinking;⑵Iodized drugs or contrast agents have been used in the past year;⑶A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
- •Lactating woman:⑴A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
- •Infants and young children:⑴Have pathological jaundice, autoimmune disease, congenital heart disease and other diseases.
结局指标
主要结局
Thyroid volume
时间窗: 24 weeks
cm³
Dried blood spot(DBS)
时间窗: 12 weeks
μg/L
Neonatal heel blood
时间窗: 1 week
μg/L
Urinary iodine excretion
时间窗: 24 weeks
μg/day
Milk iodine excretion
时间窗: 24 weeks
μg/day
Thyroid nodule
时间窗: 24 weeks
cm³
Venous blood
时间窗: baseline
μg/L
Thyroglobulin(TG)
时间窗: 1 week
ug/L
Colostrum
时间窗: 1 week
μg/L
Infant disposable random urine
时间窗: 12 weeks
μg/L
24 h urine
时间窗: 24 weeks
μg/L
Milk output
时间窗: 24 weeks
μg/day
Water iodine intake
时间窗: baseline
μg/day
Salt iodine concentration
时间窗: baseline
μg/day
Mother and child urine randomly at one time
时间窗: 1 week
μg/L
Fecal iodine excretion
时间窗: 1 week
μg/day
Disposable random urine
时间窗: baseline
μg/L
Thyroid-stimulating hormone
时间窗: 1 week
mIU/L
Average iodine intake
时间窗: 24 weeks
μg/day
Diet iodine intake
时间窗: 1 week
μg/day
次要结局
未报告次要终点
研究者
Wanqi Zhang
professor
Tianjin Medical University
