Iodine DisordersNCT02915536
Exploration of Effects of Excessive Iodine on Children and Tolerable Upper Intake Level of Iodine for Children
An observational study of Iodine Disorders, run by Wanqi Zhang.
Trial summary
With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated iodine geographical environment with wide natural variation in the iodine content of drinking water. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Iodine Disorders
- What is being tested?
- Natural exposure of high iodine
- How many people
- 2,229 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2016
- Phase
- Observational
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: High water iodine areas in Shandong are far-ranging. An investigation in 2005 showed that water iodine content exceeded 150μg/L in 17 of the 20 counties, while water iodine in the other 3 exceeded 300μg/L. Regions with water iodine content in the range of 150-800µg/L were chosen as, with a corresponding UIE range of 300-800µg/L, were selected as high iodine intake (HI) areas for the study. Regions with water iodine content in the range of 10-100µg/L with a corresponding UIE range of 100-299µg/L were selected as adequate iodine intake (AI) study areas. Areas with high fluorine will be excluded. One to six primary schools were selected from each city by randomly sampling. Children were selected from these schools.
Who may be able to join
- Healthy
- Native born or residents of Shandong province for at least 5 years.
Who cannot join
- Previous history of thyroid diseases or medication intake (including iodine supplements)
- protein-energy malnutrition in the long term
About this study
With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated iodine geographical environment with wide natural variation in the iodine content of drinking water. It has been reported that the water iodine of at least 11 provinces and cities in China is high, with nearly 31 million people exposed to the risks of excessive iodine intake. This has raised a new public health concern that a safe upper level of iodine intake should be established to ensure that people avoid ingesting excessive iodine intake while continuing to implement USI to control IDD. The investigators have successfully explored the tolerable upper intake level (UL) of iodine for Chinese adults by conducting a randomized double-blinded trial in 256 euthyroid volunteers. However, due to limited data on the safe upper intake level of iodine for children worldwide, current ULs of iodine for children are extrapolated from those for adults based on body weight or body surface area. As it is impossible to ethically conduct a randomized clinical trial regarding excessive iodine intake in children, the investigators plan an observational study to investigate children who have been living with different drinking water iodine levels for over 5 years, observing the changes of thyroid function in response to each iodine exposure level. Subtle changes in thyroid function and thyroid volume of children corresponding to different iodine intake levels will be determined, which will contribute to the establishment of UL of iodine for children.
The aim was:
- To establish the tolerable upper intake level (UL) of iodine for children of China.
- To define the adverse effects of excess iodine on children.
- To monitor the iodine status of children living in high water iodine areas in China.
Read the detailed description
The project is designed as a cross-sectional comparative epidemiological study, to be conducted in areas with high water iodine and adequate iodine intake, respectively. The research will include the following three stages.
First stage: In an initial contact phase of the study, workshops on the subject matter will be held in Shandong province. Regions will be sampled according to the monitoring data on water iodine collected by the Shandong Institute for Endemic Disease Control and Research, which will be a collaborative department for this study, as well as the pre-investigation. Areas in Shandong with water iodine ranging from 150μg/L to 800μg/L iodine, corresponding to urinary iodine excretion (UIE) of 300-800μg/L, will be investigated as high iodine intake areas (HI); regions with varying water iodine levels within this range will be included. Matching areas in Shandong with 10-100μg/L iodine in water, corresponding to UIE of 100-299μg/L, will be selected as the comparison areas of adequate iodine intake (AI). Refresher courses will be given to investigators and the capacity of laboratory staff will be updated. All relevant local authorities will be properly contacted. Pre-investigations will be conducted to determine the water iodine level and the former iodine status of residents, which will help the investigators to select suitable study areas. A pilot study will be conducted in a small number of subjects, including 24h urine collection and 3d dietary record to ensure that these methods are appropriate and feasible.
Second stage: A cross-sectional study of iodine intake and thyroid function in 7-14-yr-old children will be carried out. This stage mainly includes two parts.
In Part 1, 24-h and spot urinary samples (2 times) from all children will be collected to precisely evaluate the daily iodine intake of subjects. Spot urinary samples will be taken before collection of the 24-h urine samples. Teachers and parents will be trained to help children in performing the collection. 3d dietary records will be used to collect information on food and nutrient intake of participants. The parents (or guardian) and children will be trained on how to record food intake. The dietary record may be started any day of a week and correspond to the day of urine collection. The record will comprise all home food and water intake as well as out-of-home food consumption. Food frequency questionnaires (FFQ) will be used in combination with the dietary records to evaluate long-term habitual iodine intake. Simultaneously, food samples, including locally-consumed foods with relatively high iodine content and those which local residents generally consume frequently, will be sampled to determine iodine content, as will salt and water.
In Part 2, Blood samples will be collected to evaluate thyroid function and thyroid auto-antibodies, and thyroid volume of children will be detected by ultrasonography which will be conducted by professional technicians
Third stage: Iodine intake of all children will be calculated precisely and comprehensively through both 24-h UIE and dietary iodine intake (as described in Part 1). Adverse effects will be defined by parameters detected in Part 2.
- Conditions
- Iodine Disorders
- Being tested
- Natural exposure of high iodine
- Keywords
- iodine excess, thyroid disease, children, tolerable upper intake level
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural exposure of high iodineOther
Natural exposure of high iodine intake from drinking water
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid goiter confirmed by ultrasonographic thyroid volume
Measured: 1 year
Secondary outcomes (1)
thyroid dysfunction confirmed by serum concentrations of FT4, FT3, and TSH with an automated chemiluminescent immunoassay by using diagnostic kits from Bayer Health Care, Siemens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Iodine DisordersStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 2,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wanqi Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- The Shandong Institute for Endemic Disease Control and Research
- Responsible party
- Sponsor-investigator, Wanqi Zhang, Tianjin Medical University
- Investigators
- Wanqi Zhang, Doctor, Study chair, Tianjin Medical UniversityJianchao Bian, Principal investigator, The Shandong Institute for Endemic Disease Control and ResearchZuoliang Dong, Master, Principal investigator, Tianjin Medical UniversityLaixiang Lin, Doctor, Principal investigator, Tianjin Medical UniversityJun Shen, Master, Principal investigator, Tianjin Medical UniversityJinbiao Wang, Principal investigator, The Shandong Institute for Endemic Disease Control and ResearchWen Jiang, Master, Principal investigator, The Shandong Institute for Endemic Disease Control and ResearchZhongna Sang, Doctor, Principal investigator, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915536
- Sponsor's protocol ID
- NSFC-81273057
- Other IDs
- Nestlé Foundation, NSFC
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Teng W, Shan Z, Teng X, Guan H, Li Y, Teng D, Jin Y, Yu X, Fan C, Chong W, Yang F, Dai H, Yu Y, Li J, Chen Y, Zhao D, Shi X, Hu F, Mao J, Gu X, Yang R, Tong Y, Wang W, Gao T, Li C. Effect of iodine intake on thyroid diseases in China. N Engl J Med. 2006 Jun 29;354(26):2783-93. doi: 10.1056/NEJMoa054022.
PubMed 16807415Laurberg P, Bulow Pedersen I, Knudsen N, Ovesen L, Andersen S. Environmental iodine intake affects the type of nonmalignant thyroid disease. Thyroid. 2001 May;11(5):457-69. doi: 10.1089/105072501300176417.
PubMed 11396704Izzeldin HS, Crawford MA, Jooste PL. Population living in the Red Sea State of Sudan may need urgent intervention to correct the excess dietary iodine intake. Nutr Health. 2007;18(4):333-41. doi: 10.1177/026010600701800403.
PubMed 18087865Sang Z, Wang PP, Yao Z, Shen J, Halfyard B, Tan L, Zhao N, Wu Y, Gao S, Tan J, Liu J, Chen Z, Zhang W. Exploration of the safe upper level of iodine intake in euthyroid Chinese adults: a randomized double-blind trial. Am J Clin Nutr. 2012 Feb;95(2):367-73. doi: 10.3945/ajcn.111.028001. Epub 2011 Dec 28.
PubMed 22205314Laurberg P, Pedersen KM, Hreidarsson A, Sigfusson N, Iversen E, Knudsen PR. Iodine intake and the pattern of thyroid disorders: a comparative epidemiological study of thyroid abnormalities in the elderly in Iceland and in Jutland, Denmark. J Clin Endocrinol Metab. 1998 Mar;83(3):765-9. doi: 10.1210/jcem.83.3.4624.
PubMed 9506723Laurberg P, Cerqueira C, Ovesen L, Rasmussen LB, Perrild H, Andersen S, Pedersen IB, Carle A. Iodine intake as a determinant of thyroid disorders in populations. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):13-27. doi: 10.1016/j.beem.2009.08.013.
PubMed 20172467Su X., Liu S., Shen H., Zhang S., Wei H., Yu J., Ye Y., Li Y., Liu Y., Zhang Z., Sun D. National iodine deficiency disorder surveillance: a sum up of data in 2005 and an analysis. Chinese Journal of Endemiology. 2007, 26(1): 67-69.
Zimmermann MB, Andersson M. Assessment of iodine nutrition in populations: past, present, and future. Nutr Rev. 2012 Oct;70(10):553-70. doi: 10.1111/j.1753-4887.2012.00528.x.
PubMed 23035804Pearce EN, Gerber AR, Gootnick DB, Khan LK, Li R, Pino S, Braverman LE. Effects of chronic iodine excess in a cohort of long-term American workers in West Africa. J Clin Endocrinol Metab. 2002 Dec;87(12):5499-502. doi: 10.1210/jc.2002-020692.
PubMed 12466344Burgi H. Iodine excess. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):107-15. doi: 10.1016/j.beem.2009.08.010.
PubMed 20172475Zimmermann MB, Ito Y, Hess SY, Fujieda K, Molinari L. High thyroid volume in children with excess dietary iodine intakes. Am J Clin Nutr. 2005 Apr;81(4):840-4. doi: 10.1093/ajcn/81.4.840.
PubMed 15817861Ergur AT, Evliyaoglu O, Siklar Z, Bilir P, Ocal G, Berberoglu M. Evaluation of thyroid functions with respect to iodine status and TRH test in chronic autoimmune thyroiditis. J Clin Res Pediatr Endocrinol. 2011;3(1):18-21. doi: 10.4274/jcrpe.v3i1.04. Epub 2011 Feb 23.
PubMed 21448329Shen H., Zhang S., Liu S., Su X., Shen Y., Han H. Study on the geographic distribution of national high water iodine areas and the contours of water iodine in high iodine areas. Chinese Journal of Endemiology. 2007, 26(6): 658-661.
Guo X., Wang X., Liu Y., Huang J., Zhai L., Chen Z. Investigation of distribution of high water iodine areas of northwestern Shandong and the current status of inhabitant edible salt. Chinese Journal of Preventive Medicine. 2005, 39(2): 77-78.
WHO/UNICEF/ICCIDD. Assessment of iodine deficiency disorders and monitoring their elimination. 3rd ed. Geneva, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Effects of Excessive Iodine on Children and Tolerable Upper Intake Level of Iodine for Children
- ClinicalTrials.gov ID
- NCT02915536
- Acronym / sponsor ID
- NSFC-81273057
- Conditions
- Iodine Disorders
- Keywords
- iodine excess, thyroid disease, children, tolerable upper intake level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,229 participants (actual)
- Lead sponsor
- Wanqi ZhangUniversity, hospital or other
- Collaborators
- The Shandong Institute for Endemic Disease Control and Research
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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.
With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated iodine geographical environment with wide natural variation in the iodine content of drinking water. It has been reported that the water iodine of at least 11 provinces and cities in China is high, with nearly 31 million people exposed to the risks of excessive iodine intake. This has raised a new public health concern that a safe upper level of iodine intake should be established to ensure that people avoid ingesting excessive iodine intake while continuing to implement USI to control IDD. The investigators have successfully explored the tolerable upper intake level (UL) of iodine for Chinese adults by conducting a randomized double-blinded trial in 256 euthyroid volunteers. However, due to limited data on the safe upper intake level of iodine for children worldwide, current ULs of iodine for children are extrapolated from those for adults based on body weight or body surface area. As it is impossible to ethically conduct a randomized clinical trial regarding excessive iodine intake in children, the investigators plan an observational study to investigate children who have been living with different drinking water iodine levels for over 5 years, observing the changes of thyroid function in response to each iodine exposure level. Subtle changes in thyroid function and thyroid volume of children corresponding to different iodine intake levels will be determined, which will contribute to the establishment of UL of iodine for children.
The aim was:
- To establish the tolerable upper intake level (UL) of iodine for children of China.
- To define the adverse effects of excess iodine on children.
- To monitor the iodine status of children living in high water iodine areas in China.
Detailed description
The project is designed as a cross-sectional comparative epidemiological study, to be conducted in areas with high water iodine and adequate iodine intake, respectively. The research will include the following three stages.
First stage: In an initial contact phase of the study, workshops on the subject matter will be held in Shandong province. Regions will be sampled according to the monitoring data on water iodine collected by the Shandong Institute for Endemic Disease Control and Research, which will be a collaborative department for this study, as well as the pre-investigation. Areas in Shandong with water iodine ranging from 150μg/L to 800μg/L iodine, corresponding to urinary iodine excretion (UIE) of 300-800μg/L, will be investigated as high iodine intake areas (HI); regions with varying water iodine levels within this range will be included. Matching areas in Shandong with 10-100μg/L iodine in water, corresponding to UIE of 100-299μg/L, will be selected as the comparison areas of adequate iodine intake (AI). Refresher courses will be given to investigators and the capacity of laboratory staff will be updated. All relevant local authorities will be properly contacted. Pre-investigations will be conducted to determine the water iodine level and the former iodine status of residents, which will help the investigators to select suitable study areas. A pilot study will be conducted in a small number of subjects, including 24h urine collection and 3d dietary record to ensure that these methods are appropriate and feasible.
Second stage: A cross-sectional study of iodine intake and thyroid function in 7-14-yr-old children will be carried out. This stage mainly includes two parts.
In Part 1, 24-h and spot urinary samples (2 times) from all children will be collected to precisely evaluate the daily iodine intake of subjects. Spot urinary samples will be taken before collection of the 24-h urine samples. Teachers and parents will be trained to help children in performing the collection. 3d dietary records will be used to collect information on food and nutrient intake of participants. The parents (or guardian) and children will be trained on how to record food intake. The dietary record may be started any day of a week and correspond to the day of urine collection. The record will comprise all home food and water intake as well as out-of-home food consumption. Food frequency questionnaires (FFQ) will be used in combination with the dietary records to evaluate long-term habitual iodine intake. Simultaneously, food samples, including locally-consumed foods with relatively high iodine content and those which local residents generally consume frequently, will be sampled to determine iodine content, as will salt and water.
In Part 2, Blood samples will be collected to evaluate thyroid function and thyroid auto-antibodies, and thyroid volume of children will be detected by ultrasonography which will be conducted by professional technicians
Third stage: Iodine intake of all children will be calculated precisely and comprehensively through both 24-h UIE and dietary iodine intake (as described in Part 1). Adverse effects will be defined by parameters detected in Part 2.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- High water iodine areas in Shandong are far-ranging. An investigation in 2005 showed that water iodine content exceeded 150μg/L in 17 of the 20 counties, while water iodine in the other 3 exceeded 300μg/L. Regions with water iodine content in the range of 150-800µg/L were chosen as, with a corresponding UIE range of 300-800µg/L, were selected as high iodine intake (HI) areas for the study. Regions with water iodine content in the range of 10-100µg/L with a corresponding UIE range of 100-299µg/L were selected as adequate iodine intake (AI) study areas. Areas with high fluorine will be excluded. One to six primary schools were selected from each city by randomly sampling. Children were selected from these schools.
Key inclusion criteria (2 listed)
- Healthy
- Native born or residents of Shandong province for at least 5 years.
Key exclusion criteria (2 listed)
- Previous history of thyroid diseases or medication intake (including iodine supplements)
- protein-energy malnutrition in the long term
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 |
|---|---|---|
| Natural exposure of high iodineNatural exposure of high iodine intake from drinking water | Other | – |
Primary outcome
thyroid goiter confirmed by ultrasonographic thyroid volume
Time frame: 1 year
1 secondary outcome
thyroid dysfunction confirmed by serum concentrations of FT4, FT3, and TSH with an automated chemiluminescent immunoassay by using diagnostic kits from Bayer Health Care, Siemens
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Background: PubMed 16807415Teng W, Shan Z, Teng X, Guan H, Li Y, Teng D, Jin Y, Yu X, Fan C, Chong W, Yang F, Dai H, Yu Y, Li J, Chen Y, Zhao D, Shi X, Hu F, Mao J, Gu X, Yang R, Tong Y, Wang W, Gao T, Li C. Effect of iodine intake on thyroid diseases in China. N Engl J Med. 2006 Jun 29;354(26):2783-93. doi: 10.1056/NEJMoa054022.
- Background: PubMed 11396704Laurberg P, Bulow Pedersen I, Knudsen N, Ovesen L, Andersen S. Environmental iodine intake affects the type of nonmalignant thyroid disease. Thyroid. 2001 May;11(5):457-69. doi: 10.1089/105072501300176417.
- Background: PubMed 18087865Izzeldin HS, Crawford MA, Jooste PL. Population living in the Red Sea State of Sudan may need urgent intervention to correct the excess dietary iodine intake. Nutr Health. 2007;18(4):333-41. doi: 10.1177/026010600701800403.
- Background: PubMed 22205314Sang Z, Wang PP, Yao Z, Shen J, Halfyard B, Tan L, Zhao N, Wu Y, Gao S, Tan J, Liu J, Chen Z, Zhang W. Exploration of the safe upper level of iodine intake in euthyroid Chinese adults: a randomized double-blind trial. Am J Clin Nutr. 2012 Feb;95(2):367-73. doi: 10.3945/ajcn.111.028001. Epub 2011 Dec 28.
- Background: PubMed 9506723Laurberg P, Pedersen KM, Hreidarsson A, Sigfusson N, Iversen E, Knudsen PR. Iodine intake and the pattern of thyroid disorders: a comparative epidemiological study of thyroid abnormalities in the elderly in Iceland and in Jutland, Denmark. J Clin Endocrinol Metab. 1998 Mar;83(3):765-9. doi: 10.1210/jcem.83.3.4624.
- Background: PubMed 20172467Laurberg P, Cerqueira C, Ovesen L, Rasmussen LB, Perrild H, Andersen S, Pedersen IB, Carle A. Iodine intake as a determinant of thyroid disorders in populations. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):13-27. doi: 10.1016/j.beem.2009.08.013.
- BackgroundSu X., Liu S., Shen H., Zhang S., Wei H., Yu J., Ye Y., Li Y., Liu Y., Zhang Z., Sun D. National iodine deficiency disorder surveillance: a sum up of data in 2005 and an analysis. Chinese Journal of Endemiology. 2007, 26(1): 67-69.
- Background: PubMed 23035804Zimmermann MB, Andersson M. Assessment of iodine nutrition in populations: past, present, and future. Nutr Rev. 2012 Oct;70(10):553-70. doi: 10.1111/j.1753-4887.2012.00528.x.
- Background: PubMed 12466344Pearce EN, Gerber AR, Gootnick DB, Khan LK, Li R, Pino S, Braverman LE. Effects of chronic iodine excess in a cohort of long-term American workers in West Africa. J Clin Endocrinol Metab. 2002 Dec;87(12):5499-502. doi: 10.1210/jc.2002-020692.
- Background: PubMed 20172475Burgi H. Iodine excess. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):107-15. doi: 10.1016/j.beem.2009.08.010.
- Background: PubMed 15817861Zimmermann MB, Ito Y, Hess SY, Fujieda K, Molinari L. High thyroid volume in children with excess dietary iodine intakes. Am J Clin Nutr. 2005 Apr;81(4):840-4. doi: 10.1093/ajcn/81.4.840.
- Background: PubMed 21448329Ergur AT, Evliyaoglu O, Siklar Z, Bilir P, Ocal G, Berberoglu M. Evaluation of thyroid functions with respect to iodine status and TRH test in chronic autoimmune thyroiditis. J Clin Res Pediatr Endocrinol. 2011;3(1):18-21. doi: 10.4274/jcrpe.v3i1.04. Epub 2011 Feb 23.
- Individual participant dataSharing planned: Undecided
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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.
Wanqi Zhang, Doctor study chair
Tianjin Medical University
Jianchao Bian principal investigator
The Shandong Institute for Endemic Disease Control and Research
Zuoliang Dong, Master principal investigator
Tianjin Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Disorders, run by Wanqi Zhang.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
thyroid goiter confirmed by ultrasonographic thyroid volume (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915536, which also lists 24 linked publications.
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 29 Sep 2016.