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Completed

NCT Number: NCT03279315

An Iodine Balance Experiment

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.

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Key information

Conditions

Iodine Deficiency Nutritional Requirements

Age range

19 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, 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. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

iodized table salt, non-iodized table salt

Dietary Supplement

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.

Primary outcomes

  1. Total iodine intake and total iodine excretion

    Time frame: 12 days

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

  2. Total iodine excretion

    Time frame: 12 days

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

  3. urinary iodine concentration (UIC)

    Time frame: At the beginning of the experiment

    μg/L

  4. Thyroid function

    Time frame: At the beginning of the experiment

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

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Registry information

Official study title

Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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