Hashimoto DiseaseNCT04752202

The Influence of Reducing Diets on Changes in Thyroid Parameters in Obese Women With Hashimoto's Disease

A study testing Individually balanced elimination/reducing diets and Individually balanced reducing diets (without elimination) in people with Hashimoto Disease and Obesity, run by Medical University of Bialystok at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Hashimoto Disease, Obesity
What is being tested?: Individually balanced elimination/reducing diets and Individually balanced reducing diets (without elimination)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 sitePoland
Study dates: 29 Mar 2019to 31 Oct 2019
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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with Hashimoto's disease
BMI over 30 kg/m2
Taking the L-thyroxine, 200 mcg of 1-selenomethionine/day, and 30 mg of zinc gluconate/day throughout the study period

Who cannot join

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Dietetic and Clinical Nutrition; Medical University of Bialystok
Bialystok, 15-054

Other trials in Poland

About this study

Official title: The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering From Obesity and Hashimoto's Disease

Hashimoto's disease is listed among the most common endocrine causes of obesity. As treatment of obesity in women with Hashimoto's disease is frequently unsuccessful, the aim of this study was to evaluate the effectiveness of two different reducing diets and their influence on changes in thyroid parameters in the female patients. A six-month observational/interventional study was performed on 100 women aged 18-65 years, previously diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine. The women were randomly assigned to the test group (group A, n=50) following elimination/reducing diets, and the control group (group B, n=50) following reducing diets with the same caloric content (without elimination). Anthropometric and thyroid parameters were evaluated at the beginning, after 3 months and after 6 months of treatment.

Conditions: Hashimoto Disease, Obesity
Being tested: Individually balanced elimination/reducing diets, Individually balanced reducing diets (without elimination)
Keywords: Hashimoto, Obesity, Elimination diet, Thyroid gland, Adults
Medical subject headings: Hashimoto Disease, Obesity, Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Individually balanced elimination/reducing dietsBehavioural
Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced elimination/reducing diets, in accordance with the previously performed food sensitivity tests for 6 months. Laboratory tests for type III food sensitivity in the IgG1-3 class using the ELISA method were performed in an accredited medical laboratory. Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.
Individually balanced reducing diets (without elimination)Behavioural
Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced reducing diets (without elimination) for 6 months.Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.

Study groups in NCT04752202
Study group	Role	What they receive
Test group (group A)	Experimental	The women were randomly assigned to group A. Test group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies. Receives: Behavioral: Individually balanced elimination/reducing diets
Control group (group B)	Other	The women were randomly assigned to group B. Control group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies. Receives: Behavioral: Individually balanced reducing diets (without elimination)

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients from obesity and Hashimoto's disease.
The body weight (kg) was measured using a scale with a stadiometer.
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients suffering from obesity and Hashimoto's disease.
The height (cm) was measured using a scale with a stadiometer. This measurement is needed to calculate the Body Mass Index.
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on Body Mass Index changes in patients suffering from obesity and Hashimoto's disease.
Body Mass Index (kg/m^2) was calculated from the measurements of height and weight using a mathematical formula.
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in muscle mass in patients suffering from obesity and Hashimoto's disease.
Muscle mass (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in total body water in patients suffering from obesity and Hashimoto's disease.
Total body water (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in percent body fat in patients suffering from obesity and Hashimoto's disease.
Percent body fat (%) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Measured: This measurement was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in thyroid parameters in patients suffering from obesity and Hashimoto's disease.
Laboratory tests were performed to determine the following serum levels: TSH, fT3, fT4, anti-TPO, and anti-TG. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.
Measured: This examination was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in glucose blood level in patients suffering from obesity and Hashimoto's disease.
Laboratory tests were performed to determine glucose blood level. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.
Measured: This examination was repeated during 3 visits every 12 weeks.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in lipid profile in patients suffering from obesity and Hashimoto's disease.
Laboratory tests were performed to determine the lipid profile: total cholesterol, high-density lipoprotein (HDL), low-density (LDL) cholesterol and triglycerides. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.
Measured: This examination was repeated during 3 visits every 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201931 Oct 2019

First posted12 Feb 2021
Study start29 Mar 2019
Primary completion19 Apr 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Hashimoto DiseaseStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04752202
Sponsor's protocol ID: R-I-002/187/2019
Status last verified: Feb 2021
First submitted: 2 Feb 2021
Last updated: 15 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Song RH, Wang B, Yao QM, Li Q, Jia X, Zhang JA. The Impact of Obesity on Thyroid Autoimmunity and Dysfunction: A Systematic Review and Meta-Analysis. Front Immunol. 2019 Oct 1;10:2349. doi: 10.3389/fimmu.2019.02349. eCollection 2019.
PubMed 31681268
Rotondi M, Leporati P, Rizza MI, Clerici A, Groppelli G, Pallavicini C, La Manna A, Fonte R, Magri F, Biondi B, Chiovato L. Raised serum TSH in morbid-obese and non-obese patients: effect on the circulating lipid profile. Endocrine. 2014 Feb;45(1):92-7. doi: 10.1007/s12020-013-9928-8. Epub 2013 Mar 23.
PubMed 23526236
Moulin de Moraes CM, Mancini MC, de Melo ME, Figueiredo DA, Villares SM, Rascovski A, Zilberstein B, Halpern A. Prevalence of subclinical hypothyroidism in a morbidly obese population and improvement after weight loss induced by Roux-en-Y gastric bypass. Obes Surg. 2005 Oct;15(9):1287-91. doi: 10.1381/096089205774512537.
PubMed 16259889
Draman MS, Stechman M, Scott-Coombes D, Dayan CM, Rees DA, Ludgate M, Zhang L. The Role of Thyrotropin Receptor Activation in Adipogenesis and Modulation of Fat Phenotype. Front Endocrinol (Lausanne). 2017 Apr 19;8:83. doi: 10.3389/fendo.2017.00083. eCollection 2017.
PubMed 28469599
Krysiak R, Okopien B. The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2011 Jul;96(7):2206-15. doi: 10.1210/jc.2010-2986. Epub 2011 Apr 20.
PubMed 21508145
Carroccio A, D'Alcamo A, Cavataio F, Soresi M, Seidita A, Sciume C, Geraci G, Iacono G, Mansueto P. High Proportions of People With Nonceliac Wheat Sensitivity Have Autoimmune Disease or Antinuclear Antibodies. Gastroenterology. 2015 Sep;149(3):596-603.e1. doi: 10.1053/j.gastro.2015.05.040. Epub 2015 May 27.
PubMed 26026392
Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
PubMed 30060266
Pandit AA, Vijay Warde M, Menon PS. Correlation of number of intrathyroid lymphocytes with antimicrosomal antibody titer in Hashimoto's thyroiditis. Diagn Cytopathol. 2003 Feb;28(2):63-5. doi: 10.1002/dc.10235.
PubMed 12561021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hashimoto Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering From Obesity and Hashimoto's Disease
ClinicalTrials.gov ID: NCT04752202
Acronym / sponsor ID: R-I-002/187/2019
Conditions: Hashimoto Disease, Obesity
Keywords: Hashimoto, Obesity, Elimination diet, Thyroid gland, Adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Medical University of BialystokUniversity, hospital or other
Study start: 29 Mar 2019 (actual)
Primary completion: 19 Apr 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 12 Feb 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test group (group A)	Experimental	Behavioral: Individually balanced elimination/reducing dietsThe women were randomly assigned to group A. Test group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies.
Control group (group B)	Other	Behavioral: Individually balanced reducing diets (without elimination)The women were randomly assigned to group B. Control group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with Hashimoto's disease
BMI over 30 kg/m2
Taking the L-thyroxine, 200 mcg of 1-selenomethionine/day, and 30 mg of zinc gluconate/day throughout the study period

Key exclusion criteria (1 listed)

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
Individually balanced elimination/reducing dietsParticipants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced elimination/reducing diets, in accordance with the previously performed food sensitivity tests for 6 months. Laboratory tests for type III food sensitivity in the IgG1-3 class using the ELISA method were performed in an accredited medical laboratory. Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.	Behavioural	Test group (group A)
Individually balanced reducing diets (without elimination)Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced reducing diets (without elimination) for 6 months.Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.	Behavioural	Control group (group B)

Primary outcome

Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
The body weight (kg) was measured using a scale with a stadiometer.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients suffering from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
The height (cm) was measured using a scale with a stadiometer. This measurement is needed to calculate the Body Mass Index.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on Body Mass Index changes in patients suffering from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
Body Mass Index (kg/m^2) was calculated from the measurements of height and weight using a mathematical formula.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in muscle mass in patients suffering from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
Muscle mass (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in total body water in patients suffering from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
Total body water (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in percent body fat in patients suffering from obesity and Hashimoto's disease.
Time frame: This measurement was repeated during 3 visits every 12 weeks.
Percent body fat (%) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in thyroid parameters in patients suffering from obesity and Hashimoto's disease.
Time frame: This examination was repeated during 3 visits every 12 weeks.
Laboratory tests were performed to determine the following serum levels: TSH, fT3, fT4, anti-TPO, and anti-TG. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in glucose blood level in patients suffering from obesity and Hashimoto's disease.
Time frame: This examination was repeated during 3 visits every 12 weeks.
Laboratory tests were performed to determine glucose blood level. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.
Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in lipid profile in patients suffering from obesity and Hashimoto's disease.
Time frame: This examination was repeated during 3 visits every 12 weeks.
Laboratory tests were performed to determine the lipid profile: total cholesterol, high-density lipoprotein (HDL), low-density (LDL) cholesterol and triglycerides. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast.

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 15 Feb 2021.
Background: PubMed 31681268Song RH, Wang B, Yao QM, Li Q, Jia X, Zhang JA. The Impact of Obesity on Thyroid Autoimmunity and Dysfunction: A Systematic Review and Meta-Analysis. Front Immunol. 2019 Oct 1;10:2349. doi: 10.3389/fimmu.2019.02349. eCollection 2019.
Background: PubMed 23526236Rotondi M, Leporati P, Rizza MI, Clerici A, Groppelli G, Pallavicini C, La Manna A, Fonte R, Magri F, Biondi B, Chiovato L. Raised serum TSH in morbid-obese and non-obese patients: effect on the circulating lipid profile. Endocrine. 2014 Feb;45(1):92-7. doi: 10.1007/s12020-013-9928-8. Epub 2013 Mar 23.
Background: PubMed 16259889Moulin de Moraes CM, Mancini MC, de Melo ME, Figueiredo DA, Villares SM, Rascovski A, Zilberstein B, Halpern A. Prevalence of subclinical hypothyroidism in a morbidly obese population and improvement after weight loss induced by Roux-en-Y gastric bypass. Obes Surg. 2005 Oct;15(9):1287-91. doi: 10.1381/096089205774512537.
Background: PubMed 28469599Draman MS, Stechman M, Scott-Coombes D, Dayan CM, Rees DA, Ludgate M, Zhang L. The Role of Thyrotropin Receptor Activation in Adipogenesis and Modulation of Fat Phenotype. Front Endocrinol (Lausanne). 2017 Apr 19;8:83. doi: 10.3389/fendo.2017.00083. eCollection 2017.
Background: PubMed 21508145Krysiak R, Okopien B. The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2011 Jul;96(7):2206-15. doi: 10.1210/jc.2010-2986. Epub 2011 Apr 20.
Background: PubMed 26026392Carroccio A, D'Alcamo A, Cavataio F, Soresi M, Seidita A, Sciume C, Geraci G, Iacono G, Mansueto P. High Proportions of People With Nonceliac Wheat Sensitivity Have Autoimmune Disease or Antinuclear Antibodies. Gastroenterology. 2015 Sep;149(3):596-603.e1. doi: 10.1053/j.gastro.2015.05.040. Epub 2015 May 27.
Background: PubMed 30060266Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
Background: PubMed 12561021Pandit AA, Vijay Warde M, Menon PS. Correlation of number of intrathyroid lymphocytes with antimicrosomal antibody titer in Hashimoto's thyroiditis. Diagn Cytopathol. 2003 Feb;28(2):63-5. doi: 10.1002/dc.10235.
Individual participant dataSharing planned: No

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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.

Lucyna Ostrowska, Professor study director

Medical University of Bialystok

Dominika Gier, PhD principal investigator

Medical University of Bialystok

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 15 Feb 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 Poland. 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?

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?

Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients from obesity and Hashimoto's disease. (time frame: This measurement was repeated during 3 visits every 12 weeks.). The study lists 9 primary outcomes in all. 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 NCT04752202, which also lists 8 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 15 Feb 2021.