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临床试验/NCT04492657
NCT04492657招募中不适用

Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women

Tianjin Medical University4 个研究点 分布在 3 个国家目标入组 600 人开始时间: 2020年1月1日最近更新:
适应症

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

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

发起方
Tianjin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wanqi Zhang

professor

Tianjin Medical University

研究点 (4)

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