An Iodine Balance Experiment
|ClinicalTrials.gov Identifier: NCT03279315|
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Tianjin Medical University
Information provided by (Responsible Party):
Wanqi Zhang, Tianjin Medical University
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|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|
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 :
- Total iodine intake and total iodine excretion [ Time Frame: 12 days ]Iodine intake includes iodine from food, water and air (μg/d).
- Total iodine excretion [ Time Frame: 12 days ]Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).
- urinary iodine concentration (UIC) [ Time Frame: At the beginning of the experiment ]μg/L
- 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)
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