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出境医 / 临床实验 / Bioavailability of Iodine for Natural Kelp and Iodized Salt in Young Adults

Bioavailability of Iodine for Natural Kelp and Iodized Salt in Young Adults

Study Description
Brief Summary:

Iodine is an essential micronutrient for the production of thyroid hormones and its deficiecny remains a global problem impairing health. The primary source of iodine is the diet via consumption of foods, including cooked foods with iodized salt, dairy products, or naturally abundant seafood. Currently, the recommendation of dietary iodine intake is 150 μg per day in adults who are not pregnant or lactating. The ingestion of iodine or exposure above this threshold is well-tolerated and nearly no health problems are observed. The diets processed and cooked with iodized salt are generally important iodine sources, however, high iodine intake is a result of routine consumption of several kinds of edible algae in coastal regions, with varying contributions depending on the amount of seafood consumed.

Iodine absorption mainly depends on the iodine species in foods and possibly on the iodine status of the individual. Further, there was little available data on iodine absorption or bioavailability from different dietary sources, such as natutal kelp and fortified food with potassium iodide. To our knowledge, inorganic iodide is thought to be absorbed almost completely (over 90%). However, only about two-thirds of some forms of organically-bound iodine are absorbed. The different sources of iodine absorption have not been accurately quantified and compared in humans. Therefore, the purposes of this study were to quantify the iodine absorption of natural kelp in male and female adults and compare with the bioavailability from an iodine water solution (potassium iodide). This stduy will obtain the actual iodine bioavailability and the difference for different source of foods.

This study is a randomized, cross-over design and aims to evaluate the iodine bioavailability (measured using excretion in urine and fece) from different source and administered dose of iodine, such as natural kelp and potassium iodide delivering a dialy iodine intake about 600 µg and 1200 µg. This study will compare and measure to the ingestion of natural kelp and potassium iodide within one subject by three stages: (1) normal iodine intake stage (iodine intake >150 µg/day); (2) intervention stage, a bowl of soup with an extrinsic iodine dose of about 600 µg; or a bowl of natural kelp with a certain iodine content of about 1200 µg potassium iodide.


Condition or disease Intervention/treatment Phase
Iodine Bioavailability Dietary Supplement: iodine-containg spareribs soup Dietary Supplement: intrinsic iodine in natural kelp Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Iodine Bioavailability From Different Sources of Dietary Iodine Intake in Human Trail
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : May 12, 2022
Estimated Study Completion Date : May 12, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Potassium iodide group
administrated the subjects with 150 ml - 200 ml iodine-containing spareribs soup delivering ≈ 600 µg or 1200 µg iodine
 Dietary Supplement: intrinsic iodine in natural kelp
administrated 45 g or 80 g natural kelp delivering ≈ 600 µg or 1200 µg iodine (intrinsic iodine). The natural kelp will be approximately produced in an experimental barn feeding supplementary iodine to reach a final iodine intake of ≈ 600 µg or 1200 µg. The iodine intake of natural kelp will be adjusted to the required dose by determing iodine content in the natural kelp.
Experimental: Natural kelp group
administrated the subjects with a bowl of 45 g or 80 g natural kelp delivering ≈ 600 µg or 1200 µg iodine (intrinsic iodine in natural kelp).
 Dietary Supplement: iodine-containg spareribs soup
administrated a 150 ml - 200 ml of iodine-containg spareribs soup delivering ≈ 600 µg or 1200 µg iodine
Outcome Measures
Primary Outcome Measures :
  1. Urinary Iodine concentration [ Time Frame: Time Frame: Day 1th, 2nd, 3rd, 8th, 9th, 10th, 15th, 16th and 17th ]
    measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.


Secondary Outcome Measures :
  1. Sex [ Time Frame: 1 day At screening ]
    male and female

  2. Body Mass Index (BMI) [ Time Frame: 1 day At screening ]
    BMI calculated from measured weight and height.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All, half male and half female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18 and 25 years; BMI 19-25 kg/m2; Current use of iodized salt at home, adequate iodine nutritional status; Volunteer to participate in and comply with the requirement of study; Signed informed consent.

Exclusion Criteria:

  • 1. Having history of thyroid diseases or thyroid dysfunction; 2. Inadequate iodine status (defined as mUIC <100 µg/L or >300 µg/L and assessed during screening by 3-days 24-h urine specimens) 3. Any metabolic, gastrointestinal or chronic disease or chronic use of medications or drug abuse 4. Use of iodine containing supplements within 1 month prior to study start or exposure to iodine-containing X-ray/ computed tomography contrast agent or often use of iodine-containing disinfectants 5. Cannot comply with the requirement of study or cannot delivered the excremental specimens on schedule
Contacts and Locations

Locations
Layout table for location information
China, Shanxi
Changzhi Medical College
Changzhi, Shanxi, China, 046000
Sponsors and Collaborators
Liu Xiao Bing
Changzhi Medical College
Shenzhen Center for Chronic Disease Control
Investigators
Layout table for investigator information
Principal Investigator: Xiaoguang Yang, Ph.D National Institute of Nutrition and Health, China CDC
Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE May 11, 2021
Estimated Primary Completion Date May 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		Urinary Iodine concentration [ Time Frame: Time Frame: Day 1th, 2nd, 3rd, 8th, 9th, 10th, 15th, 16th and 17th ]
measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • Sex [ Time Frame: 1 day At screening ]
    male and female
  • Body Mass Index (BMI) [ Time Frame: 1 day At screening ]
    BMI calculated from measured weight and height.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Iodine for Natural Kelp and Iodized Salt in Young Adults
Official Title  ICMJE Iodine Bioavailability From Different Sources of Dietary Iodine Intake in Human Trail
Brief Summary

Iodine is an essential micronutrient for the production of thyroid hormones and its deficiecny remains a global problem impairing health. The primary source of iodine is the diet via consumption of foods, including cooked foods with iodized salt, dairy products, or naturally abundant seafood. Currently, the recommendation of dietary iodine intake is 150 μg per day in adults who are not pregnant or lactating. The ingestion of iodine or exposure above this threshold is well-tolerated and nearly no health problems are observed. The diets processed and cooked with iodized salt are generally important iodine sources, however, high iodine intake is a result of routine consumption of several kinds of edible algae in coastal regions, with varying contributions depending on the amount of seafood consumed.

Iodine absorption mainly depends on the iodine species in foods and possibly on the iodine status of the individual. Further, there was little available data on iodine absorption or bioavailability from different dietary sources, such as natutal kelp and fortified food with potassium iodide. To our knowledge, inorganic iodide is thought to be absorbed almost completely (over 90%). However, only about two-thirds of some forms of organically-bound iodine are absorbed. The different sources of iodine absorption have not been accurately quantified and compared in humans. Therefore, the purposes of this study were to quantify the iodine absorption of natural kelp in male and female adults and compare with the bioavailability from an iodine water solution (potassium iodide). This stduy will obtain the actual iodine bioavailability and the difference for different source of foods.

This study is a randomized, cross-over design and aims to evaluate the iodine bioavailability (measured using excretion in urine and fece) from different source and administered dose of iodine, such as natural kelp and potassium iodide delivering a dialy iodine intake about 600 µg and 1200 µg. This study will compare and measure to the ingestion of natural kelp and potassium iodide within one subject by three stages: (1) normal iodine intake stage (iodine intake >150 µg/day); (2) intervention stage, a bowl of soup with an extrinsic iodine dose of about 600 µg; or a bowl of natural kelp with a certain iodine content of about 1200 µg potassium iodide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Iodine Bioavailability
Intervention  ICMJE
  • Dietary Supplement: iodine-containg spareribs soup
    administrated a 150 ml - 200 ml of iodine-containg spareribs soup delivering ≈ 600 µg or 1200 µg iodine
  • Dietary Supplement: intrinsic iodine in natural kelp
    administrated 45 g or 80 g natural kelp delivering ≈ 600 µg or 1200 µg iodine (intrinsic iodine). The natural kelp will be approximately produced in an experimental barn feeding supplementary iodine to reach a final iodine intake of ≈ 600 µg or 1200 µg. The iodine intake of natural kelp will be adjusted to the required dose by determing iodine content in the natural kelp.
Study Arms  ICMJE
  • Experimental: Potassium iodide group
    administrated the subjects with 150 ml - 200 ml iodine-containing spareribs soup delivering ≈ 600 µg or 1200 µg iodine
    Intervention: Dietary Supplement: intrinsic iodine in natural kelp
  • Experimental: Natural kelp group
    administrated the subjects with a bowl of 45 g or 80 g natural kelp delivering ≈ 600 µg or 1200 µg iodine (intrinsic iodine in natural kelp).
    Intervention: Dietary Supplement: iodine-containg spareribs soup
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 12, 2024
Estimated Primary Completion Date May 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 and 25 years; BMI 19-25 kg/m2; Current use of iodized salt at home, adequate iodine nutritional status; Volunteer to participate in and comply with the requirement of study; Signed informed consent.

Exclusion Criteria:

  • 1. Having history of thyroid diseases or thyroid dysfunction; 2. Inadequate iodine status (defined as mUIC <100 µg/L or >300 µg/L and assessed during screening by 3-days 24-h urine specimens) 3. Any metabolic, gastrointestinal or chronic disease or chronic use of medications or drug abuse 4. Use of iodine containing supplements within 1 month prior to study start or exposure to iodine-containing X-ray/ computed tomography contrast agent or often use of iodine-containing disinfectants 5. Cannot comply with the requirement of study or cannot delivered the excremental specimens on schedule
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: All, half male and half female
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04933279
Other Study ID Numbers  ICMJE CTR2021000617
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Liu Xiao Bing, Nationtial Institute of Nutrition and Health, China CDC
Study Sponsor  ICMJE Liu Xiao Bing
Collaborators  ICMJE
  • Changzhi Medical College
  • Shenzhen Center for Chronic Disease Control
Investigators  ICMJE
Principal Investigator: Xiaoguang Yang, Ph.D National Institute of Nutrition and Health, China CDC
PRS Account Nationtial Institute of Nutrition and Health, China CDC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP