The Effect of Iodine Intakes on Maternal and Infant Health and the Study of Iodine RNI for Different Stages of Pregnancy

NCT03710148 | Unknown

• 1 other identifier: NSFC-81330064
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

1. 1.The study of effect on mothers and their infants of the lack of iodine at different gestation in adequate iodine area.
2. 2.The study of recommended iodine intake (RNI) for healthy pregnant women in three pregnancy.
3. 3.The study of effect of different levels of high iodine exposure on pregnant women, delivery women and their infants.

Conditions

Iodine Reaction; Iodine Compounds Overdose; Pregnancy Related

Keywords

Iodine; Estimated Average Requirement; Recommended Nutritent Intake; Tolerable Upper Intake Level; Pregnant Women; Pregnancy; EAR; RNI; UL

Outcome Measures

Primary Outcomes (4)

• Thyroid goiter confirmed by ultrasonographic thyroid volume

  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.

  3 years

• Thyroid dysfunction confirmed by serum concentrations of FT3, FT4, TSH ,TPOAB and TGAb

  Thyroid function is not in the normal reference range and is defined as thyroid dysfunction

  3 years

• Evaluation of neuropsychological development of children at age 2

  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.

  2 years

• Iodine intake were measured by Iodine balance experiment

  24h iodine intake =24h dietary iodine intake + 24h water iodine intake + 24h respiratory iodine intake

  1 years

Interventions

Natural exposure of deficient or excessive iodine OTHER

Natural exposure of deficient iodine from diet \& drinking water, and of excessive iodine intake from drinking water

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women were recruited at Tanggu Maternity Hospital and Maternal, Tianjin Child Health Care Service Center and the Maternal and Gaoqing Child Health Hospital, Shandong.

You may qualify if:

• \) 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.

Sponsors & Collaborators

• Shandong Institute for Endemic Disease Control and Research: collaborator
• Wanqi Zhang: lead
• Tianjin Maternal and Child Health Care Center: collaborator

Study Sites (3)

Gaoqing Maternal and Child Health Care Center

Zibo, Shandong, China

RECRUITING

Tanggu Maternity Hospital

Tianjin, China

RECRUITING

Tianjin Maternal and Child Health Care Center

Tianjin, China

COMPLETED

Related Publications (32)

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Study Officials

• Ping Shao, Master

  Tianjin Maternal and Child Health Care Center

  PRINCIPAL INVESTIGATOR

• Xiaoming Wang, Master

  Shandong Institute for Endemic Disease Control and Research

  PRINCIPAL INVESTIGATOR

• Laixing Lin, Master

  Tianjin Medical University Metabolic Diseases Hospital

  PRINCIPAL INVESTIGATOR

• Jun Shen, Master

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Long Tan, PhD

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Wen Chen, PhD

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Wei Wang, BA

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Tingkai Cui, BA

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Min Gao, BA

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Yanting Chen, BA

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Wenxing Guo, BA

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Chongdan Wang, BA

  Tanggu Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanqi Zhang, PhD

CONTACT

(86) 22 83336595; wqzhang@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Dean for School of Public Health

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: January 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

CN (3)