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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04492657
Enrollment
600
Registered
2020-07-30
Start date
2020-01-01
Completion date
2024-12-31
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Requirements

Keywords

public nutrition, nutrition of special population, lactating women and infants, physiological compensatory mechanism, iodine balance study

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.

Interventions

OTHERno intervention

Natural exposure of iodine.

Sponsors

Tianjin Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Days to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Disposable random urinebaselineμg/L
Venous bloodbaselineμg/L
Water iodine intakebaselineμg/day
Salt iodine concentrationbaselineμg/day
Colostrum1 weekμg/L
Mother and child urine randomly at one time1 weekμg/L
Neonatal heel blood1 weekμg/L
Thyroglobulin(TG)1 weekug/L
Thyroid-stimulating hormone1 weekmIU/L
Infant disposable random urine4 weeksμg/L
24 h urine4 weeksμg/L
Urinary iodine excretion4 weeksμg/day
Milk output4 weeksμg/day
Milk iodine excretion4 weeksμg/day
Average iodine intake4 weeksμg/day
Thyroid volume1 weekcm³
Thyroid nodule1 weekcm³
Dried blood spot(DBS)3 daysμg/L
Diet iodine intake1 weekμg/day
Fecal iodine excretion1 weekμg/day

Countries

China, Switzerland, United States

Contacts

Primary ContactWanQi Zhang, doctorate
wqzhang@tmu.edu.cn022-83336595
Backup Contactying Ye
yeying@tmu.edu.cn022-83336717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026