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An Iodine Balance Experiment

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ClinicalTrials.gov Identifier: NCT03279315
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Wanqi Zhang, Tianjin Medical University

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.

Condition or disease Intervention/treatment Phase
Iodine Deficiency Nutritional Requirements Dietary Supplement: iodized table salt, non-iodized table salt Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants received a diet with iodized table salt or non-iodized table salt
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment
Actual Study Start Date : November 20, 2014
Actual Primary Completion Date : December 19, 2014
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
Drug Information available for: Iodine

Arm Intervention/treatment
Experimental: experimental period
the first period was with non-iodized salt, the second period was with iodized salt.
Dietary Supplement: iodized table salt, non-iodized table salt
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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Wanqi Zhang, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT03279315    
Other Study ID Numbers: NSFC-31340033
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wanqi Zhang, Tianjin Medical University:
Iodine
Balance experiment
EAR
Chinese women
Euthyroid