Clinical trial NCT04492657: Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
Official title: Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Requirements
Keywords: public nutrition
nutrition of special population
lactating women and infants
physiological compensatory mechanism
iodine balance study
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the third trimester (18-40 years old), lactating women (38-42 weeks of gestation) and infants (0-6 months), all from Tianjin, Hebei and Shandong

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disposable random urine
timeFrame: baseline
measure: Venous blood
timeFrame: baseline
measure: Water iodine intake
timeFrame: baseline
measure: Salt iodine concentration
timeFrame: baseline
measure: Colostrum
timeFrame: 1 week
measure: Mother and child urine randomly at one time
timeFrame: 1 week
measure: Neonatal heel blood
timeFrame: 1 week
measure: Thyroglobulin(TG)
timeFrame: 1 week
measure: Thyroid-stimulating hormone
timeFrame: 1 week
measure: Infant disposable random urine
timeFrame: 4 weeks
measure: Infant disposable random urine
timeFrame: 24 weeks
measure: Infant disposable random urine
timeFrame: 12 weeks
measure: 24 h urine
timeFrame: 4 weeks
measure: 24 h urine
timeFrame: 12 weeks
measure: 24 h urine
timeFrame: 24 weeks
measure: Urinary iodine excretion
timeFrame: 4 weeks
measure: Urinary iodine excretion
timeFrame: 12 weeks
measure: Urinary iodine excretion
timeFrame: 24 weeks
measure: Milk output
timeFrame: 4 weeks
measure: Milk output
timeFrame: 12 weeks
measure: Milk output
timeFrame: 24 weeks
measure: Milk iodine excretion
timeFrame: 4 weeks
measure: Milk iodine excretion
timeFrame: 12 weeks
measure: Milk iodine excretion
timeFrame: 24 weeks
measure: Average iodine intake
timeFrame: 4 weeks
measure: Average iodine intake
timeFrame: 12 weeks
measure: Average iodine intake
timeFrame: 24 weeks
measure: Thyroid volume
timeFrame: 1 week
measure: Thyroid volume
timeFrame: 4 weeks
measure: Thyroid volume
timeFrame: 12 weeks
measure: Thyroid volume
timeFrame: 24 weeks
measure: Thyroid nodule
timeFrame: 1 week
measure: Thyroid nodule
timeFrame: 4 weeks
measure: Thyroid nodule
timeFrame: 12 weeks
measure: Thyroid nodule
timeFrame: 24 weeks
measure: Dried blood spot(DBS)
timeFrame: 3 days
measure: Dried blood spot(DBS)
timeFrame: 12 weeks
measure: Diet iodine intake
timeFrame: 1 week
measure: Fecal iodine excretion
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine; Iodine Global Network (IGN)
state: Massachusetts
city: Beijing
country: China
facility: Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
city: Shandong
country: China
facility: Shandong Institute of Endemic Disease Control and Prevention
city: Zurich
country: Switzerland
facility: Swiss federal institute of Technology (ETH)
Study officials:
affiliation: Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
name: JianQiang Lai
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Institute of Endemic Disease Control and Prevention
name: XueSong Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
name: YiFan Duan
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: GuiJun Tan
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: Wen Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: YanTing Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: Min Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: ZiYun Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss federal institute of Technology (ETH)
name: Michael B Zimmermann, doctorate
role: STUDY_CHAIR
affiliation: Boston University School of Medicine; Iodine Global Network (IGN)
name: Elizabeth N Pearce, doctorate
role: STUDY_CHAIR
affiliation: Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
name: Maria Andersson, doctorate
role: STUDY_CHAIR
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