Iodine BioavailabilityNCT04933279
Bioavailability of Iodine for Natural Kelp and Iodized Salt in Young Adults
A study testing iodine-containg spareribs soup and intrinsic iodine in natural kelp in people with Iodine Bioavailability, run by Liu Xiao Bing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Bioavailability
- What is being tested?
- iodine-containg spareribs soup and intrinsic iodine in natural kelp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 12 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iodine Bioavailability From Different Sources of Dietary Iodine Intake in Human Trail
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.
- Conditions
- Iodine Bioavailability
- Being tested
- iodine-containg spareribs soup, intrinsic iodine in natural kelp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine-containg spareribs soupDietary supplement
administrated a 150 ml - 200 ml of iodine-containg spareribs soup delivering ≈ 600 µg or 1200 µg iodine
intrinsic iodine in natural kelpDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Potassium iodide group | Experimental | administrated the subjects with 150 ml - 200 ml iodine-containing spareribs soup delivering ≈ 600 µg or 1200 µg iodine Receives: Dietary Supplement: intrinsic iodine in natural kelp |
| Natural kelp group | Experimental | 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). Receives: Dietary Supplement: iodine-containg spareribs soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Iodine concentration
measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.
Measured: Time Frame: Day 1th, 2nd, 3rd, 8th, 9th, 10th, 15th, 16th and 17th
Secondary outcomes (2)
Sex
male and female
Measured: 1 day At screening
Body Mass Index (BMI)
BMI calculated from measured weight and height.
Measured: 1 day At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start11 May 2021
- Primary completion12 May 2022 (estimated)
- Study completion12 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Xiao Bing
- Sponsor type
- University, hospital or other
- Collaborators
- Changzhi Medical College, Shenzhen Center for Chronic Disease Control
- Responsible party
- Sponsor-investigator, Liu Xiao Bing, Nationtial Institute of Nutrition and Health, China CDC
- Investigators
- Xiaoguang Yang, Ph.D, Principal investigator, National Institute of Nutrition and Health, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933279
- Sponsor's protocol ID
- CTR2021000617
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Bioavailability From Different Sources of Dietary Iodine Intake in Human Trail
- ClinicalTrials.gov ID
- NCT04933279
- Acronym / sponsor ID
- CTR2021000617
- Conditions
- Iodine Bioavailability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Liu Xiao BingUniversity, hospital or other
- Collaborators
- Changzhi Medical College, Shenzhen Center for Chronic Disease Control
- Study start
- 11 May 2021 (actual)
- Primary completion
- 12 May 2022 (estimated)
- Study completion
- 12 May 2024 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium iodide group | Experimental | Dietary Supplement: intrinsic iodine in natural kelpadministrated the subjects with 150 ml - 200 ml iodine-containing spareribs soup delivering ≈ 600 µg or 1200 µg iodine |
| Natural kelp group | Experimental | Dietary Supplement: iodine-containg spareribs soupadministrated 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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iodine-containg spareribs soupadministrated a 150 ml - 200 ml of iodine-containg spareribs soup delivering ≈ 600 µg or 1200 µg iodine | Dietary supplement | Natural kelp group |
| intrinsic iodine in natural kelpadministrated 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. | Dietary supplement | Potassium iodide group |
Primary outcome
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.
2 secondary outcomes
Sex
Time frame: 1 day At screening
Body Mass Index (BMI)
Time frame: 1 day At screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Iodine Bioavailability
Not yet recruiting
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
Micronutrient Status
Active, not recruiting
The Bioavailability of Iodine in Plant-based Milk Alternatives
Iodine Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoguang Yang, Ph.D principal investigator
National Institute of Nutrition and Health, China CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iodine-containg spareribs soup and intrinsic iodine in natural kelp in people with Iodine Bioavailability, run by Liu Xiao Bing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Iodine concentration (time frame: Time Frame: Day 1th, 2nd, 3rd, 8th, 9th, 10th, 15th, 16th and 17th). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.