NCT03279315

Brief Summary

A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2014

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

29 days

First QC Date

September 7, 2017

Last Update Submit

September 8, 2017

Conditions

Keywords

IodineBalance experimentEARChinese womenEuthyroid

Outcome Measures

Primary Outcomes (4)

  • Total iodine intake and total iodine excretion

    Iodine intake includes iodine from food, water and air (μg/d).

    12 days

  • Total iodine excretion

    Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).

    12 days

  • urinary iodine concentration (UIC)

    μg/L

    At the beginning of the experiment

  • Thyroid function

    FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)

    At the beginning of the experiment

Study Arms (1)

experimental period

EXPERIMENTAL

the first period was with non-iodized salt, the second period was with iodized salt.

Dietary Supplement: iodized table salt, non-iodized table salt

Interventions

During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.

experimental period

Eligibility Criteria

Age19 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.

You may not qualify if:

  • The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang Y, Tian X, Song Q, Wang W, Guo X, Cui T, Pan Z, Chen Y, Chen W, Tan L, Zhang W. Application and Comparison of Different Regression Models in Iodine Balance Experiment on Women of Childbearing Age and Pregnant Women. Biol Trace Elem Res. 2024 Jun;202(6):2474-2487. doi: 10.1007/s12011-023-03867-x. Epub 2023 Oct 9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Participants received a diet with iodized table salt or non-iodized table salt
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 12, 2017

Study Start

November 20, 2014

Primary Completion

December 19, 2014

Study Completion

March 10, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share