Pregnancy RelatedNCT06527859

Correlation Between Levothyroxine and Blood Th17/Treg in Pregnant Women With Normal-high TSH and Positive TPOAb

An observational study of Pregnancy Related and Thyroid Stimulating; Hormone, C, run by Third Affiliated Hospital of Zhengzhou University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this clinical trial is to understand the impact of different doses of levothyroxine on the immune inflammatory response in pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Related, Thyroid Stimulating; Hormone, C
What is being tested?: Levothyroxin
How many people: 64 participants
Where: 1 siteChina
Study dates: 6 Apr 2022to 5 Jun 2024
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: The population that meets the inclusion and exclusion criteria and is willing to participate in the research.

Who may be able to join

Thyroid function level meets the specific reference range established by the laboratory department of our hospital based on the "Guidelines for the prevention and management of thyroid diseases during pregnancy and perinatal period" : FT4: 12-22pmol/L; disease group: TPOAb>;34IU/mL, TSH: 2.5mIU/L-upper limit of reference range; control group: TPOAb≤34IU/mL, TSH<2.5mIU/L;
All pregnant women are in the first half of pregnancy (gestational age≤20 weeks).

Who cannot join

Combined with hypothyroidism, subclinical hypothyroidism, and hyperthyroidism;
Assisted reproduction;
Multiple pregnancy;
Combined with other autoimmune diseases such as antiphospholipid syndrome and thrombophilia;
Severe intestinal diseases or intestinal surgery history, or the use of probiotics, prebiotics and other drugs that affect intestinal flora;
Obesity, pre-pregnancy hyperlipidemia;
Adverse reactions to LT4

Trial locations and contacts

1 site in 1 country.

China1 site

The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan

Other trials in China

About this study

Official title: Correlation Between Different Doses of Levothyroxine Supplementation and Peripheral Blood Th17/Treg Balance in Pregnant Women With Normal-high TSH and Positive TPOAb in the First Half of Pregnancy

Are there differences in immune inflammation between normal pregnant women and those in the disease group? Can different doses of levothyroxine improve the Th17/Treg ratio and cytokine levels in the disease group? Researchers first compared the differences between normal pregnant women and those in the disease group, and then administered two different doses of levothyroxine to the disease group to observe whether different doses of levothyroxine can improve the immune inflammation in this group.

pregnant women in the disease group will: Take the same dose of levothyroxine (25/50ug) every day Return for a follow-up visit after 4 weeks of medication

Read the detailed description

To explore the correlation between different doses of levothyroxine (LT4) supplementation and Th17/Treg and cytokines in pregnant women with normal-high thyroid stimulating hormone (TSH) and positive thyroid peroxidase antibody (TPOAb) in the first half of pregnancy. From June 2022 to October 2023, 34 pregnant women with high- normal TSH and positive TPOAb in our hospital were selected (disease group), and 30 healthy pregnant women (control group) were matched; the disease group was divided into HA group and HB group according to the administration of 25 ug LT4 and 50 ug LT4. Blood samples were collected from the control group and the disease group before and 4-8 weeks after intervention to detect thyroid function, cytokine and blood lipid levels, flow cytometry to determine the proportion of Th17 and Treg cells, and methane hydrogen blowing examination was performed in parallel; the serological differences between the groups and before and after intervention were compared, and correlation analysis was used to analyze thyroid function, blood lipids, cytokines, and Th17/Treg.

Conditions: Pregnancy Related, Thyroid Stimulating; Hormone, C
Being tested: Levothyroxin
Keywords: levothyroxine, thyroid stimulating hormone, thyroid peroxidase antibodies, immunity, Th17/Treg

What participants receive

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

LevothyroxinDrug
The disease group were divided into two groups ,25ugLT4 (HA group, n=17) and 50ugLT4 (HB group, n=17) respectively.

Study groups in NCT06527859
Study group	Role	What they receive
control group		healthy pregnancy women
disease group		pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy Receives: Drug: Levothyroxin

What is being measured

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

Th17/Treg
Ratio of Th17 to Treg percentages in peripheral blood.
Measured: 4 weeks

Secondary outcomes (1)

cytokines, inflammatory factor
Concentrations of IL-2, 4, 6, 10, TNF-α, and hsCRP in peripheral blood.
Measured: 4 weeks

Timeline

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

6 Apr 20225 Jun 2024

First posted30 Jul 2024
Study start6 Apr 2022
Primary completion31 Oct 2023
Study completion5 Jun 2024

Why it stopped: The study was terminated due to insufficient funding, rendering it impossible to continue purchasing reagents for experiments

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies 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
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06527859
Sponsor's protocol ID: ThirdZhengzhouU
Status last verified: Jul 2024
First submitted: 14 Jul 2024
Last updated: 30 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lasa M, Contreras-Jurado C. Thyroid hormones act as modulators of inflammation through their nuclear receptors. Front Endocrinol (Lausanne). 2022 Aug 8;13:937099. doi: 10.3389/fendo.2022.937099. eCollection 2022.
PubMed 36004343
Michalopoulou G, Alevizaki M, Piperingos G, Mitsibounas D, Mantzos E, Adamopoulos P, Koutras DA. High serum cholesterol levels in persons with 'high-normal' TSH levels: should one extend the definition of subclinical hypothyroidism? Eur J Endocrinol. 1998 Feb;138(2):141-5. doi: 10.1530/eje.0.1380141.
PubMed 9506856
Cayres LCF, de Salis LVV, Rodrigues GSP, Lengert AVH, Biondi APC, Sargentini LDB, Brisotti JL, Gomes E, de Oliveira GLV. Detection of Alterations in the Gut Microbiota and Intestinal Permeability in Patients With Hashimoto Thyroiditis. Front Immunol. 2021 Mar 5;12:579140. doi: 10.3389/fimmu.2021.579140. eCollection 2021.
PubMed 33746942
Xue H, Yu X, Ma L, Song S, Li Y, Zhang L, Yang T, Liu H. The possible role of CD4(+)CD25(high)Foxp3(+)/CD4(+)IL-17A(+) cell imbalance in the autoimmunity of patients with Hashimoto thyroiditis. Endocrine. 2015 Dec;50(3):665-73. doi: 10.1007/s12020-015-0569-y. Epub 2015 Mar 13.
PubMed 25771887
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Xue H, Yang Y, Zhang Y, Song S, Zhang L, Ma L, Yang T, Liu H. Macrophage migration inhibitory factor interacting with Th17 cells may be involved in the pathogenesis of autoimmune damage in Hashimoto's thyroiditis. Mediators Inflamm. 2015;2015:621072. doi: 10.1155/2015/621072. Epub 2015 Mar 15.
PubMed 25861163
Lee SY, Pearce EN. Assessment and treatment of thyroid disorders in pregnancy and the postpartum period. Nat Rev Endocrinol. 2022 Mar;18(3):158-171. doi: 10.1038/s41574-021-00604-z. Epub 2022 Jan 4.
PubMed 34983968
Yetkin DO, Dogantekin B. The Lipid Parameters and Lipoprotein(a) Excess in Hashimoto Thyroiditis. Int J Endocrinol. 2015;2015:952729. doi: 10.1155/2015/952729. Epub 2015 May 3.
PubMed 26064115
Sinha RA, Singh BK, Yen PM. Direct effects of thyroid hormones on hepatic lipid metabolism. Nat Rev Endocrinol. 2018 May;14(5):259-269. doi: 10.1038/nrendo.2018.10. Epub 2018 Feb 23.
PubMed 29472712
Kim HJ, Park SJ, Park HK, Byun DW, Suh K, Yoo MH. Thyroid autoimmunity and metabolic syndrome: a nationwide population-based study. Eur J Endocrinol. 2021 Oct 11;185(5):707-715. doi: 10.1530/EJE-21-0634.
PubMed 34519275
Ru X, Yang M, Teng Y, Han Y, Hu Y, Wang J, Tao F, Huang K. Association of maternal thyroid peroxidase antibody during pregnancy with placental morphology and inflammatory and oxidative stress responses. Front Endocrinol (Lausanne). 2023 Sep 22;14:1182049. doi: 10.3389/fendo.2023.1182049. eCollection 2023.
PubMed 37810887
Mahto M, Chakraborthy B, Gowda SH, Kaur H, Vishnoi G, Lali P. Are hsCRP Levels and LDL/HDL Ratio Better and Early Markers to Unmask Onset of Dyslipidemia and Inflammation in Asymptomatic Subclinical Hypothyroidism? Indian J Clin Biochem. 2012 Jul;27(3):284-9. doi: 10.1007/s12291-012-0206-y. Epub 2012 Apr 18.
PubMed 26405389
Cao Y, Jin X, Sun Y, Wen W. Therapeutic effect of mesenchymal stem cell on Hashimoto's thyroiditis in a rat model by modulating Th17/Treg cell balance. Autoimmunity. 2020 Feb;53(1):35-45. doi: 10.1080/08916934.2019.1697689. Epub 2019 Dec 3.
PubMed 31793369
Vaivode I, Zake T, Strele I, Upmale-Engela S, Gogins D, Gersone G, Skesters A, Dambrova M, Konrade I. Stress-Related Immune Response and Selenium Status in Autoimmune Thyroid Disease Patients. Int J Mol Sci. 2023 Jan 26;24(3):2440. doi: 10.3390/ijms24032440.
PubMed 36768762
Mazzieri A, Montanucci P, Basta G, Calafiore R. The role behind the scenes of Tregs and Th17s in Hashimoto's thyroiditis: Toward a pivotal role of FOXP3 and BACH2. Front Immunol. 2022 Dec 12;13:1098243. doi: 10.3389/fimmu.2022.1098243. eCollection 2022.
PubMed 36578493

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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation Between Different Doses of Levothyroxine Supplementation and Peripheral Blood Th17/Treg Balance in Pregnant Women With Normal-high TSH and Positive TPOAb in the First Half of Pregnancy
ClinicalTrials.gov ID: NCT06527859
Acronym / sponsor ID: ThirdZhengzhouU
Conditions: Pregnancy Related, Thyroid Stimulating; Hormone, C
Keywords: levothyroxine, thyroid stimulating hormone, thyroid peroxidase antibodies, immunity, Th17/Treg
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated due to insufficient funding, rendering it impossible to continue purchasing reagents for experiments
Enrolment: 64 participants (actual)
Lead sponsor: Third Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
Study start: 6 Apr 2022 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 5 Jun 2024 (actual)
First posted: 30 Jul 2024 (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.

pregnant women in the disease group will: Take the same dose of levothyroxine (25/50ug) every day Return for a follow-up visit after 4 weeks of medication

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
control group	–	–healthy pregnancy women
disease group	–	Drug: Levothyroxinpregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: The population that meets the inclusion and exclusion criteria and is willing to participate in the research.

Key inclusion criteria (2 listed)

Thyroid function level meets the specific reference range established by the laboratory department of our hospital based on the "Guidelines for the prevention and management of thyroid diseases during pregnancy and perinatal period" : FT4: 12-22pmol/L; disease group: TPOAb>;34IU/mL, TSH: 2.5mIU/L-upper limit of reference range; control group: TPOAb≤34IU/mL, TSH<2.5mIU/L;
All pregnant women are in the first half of pregnancy (gestational age≤20 weeks).

Key exclusion criteria (7 listed)

Combined with hypothyroidism, subclinical hypothyroidism, and hyperthyroidism;
Assisted reproduction;
Multiple pregnancy;
Combined with other autoimmune diseases such as antiphospholipid syndrome and thrombophilia;
Severe intestinal diseases or intestinal surgery history, or the use of probiotics, prebiotics and other drugs that affect intestinal flora;

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
LevothyroxinThe disease group were divided into two groups ,25ugLT4 (HA group, n=17) and 50ugLT4 (HB group, n=17) respectively.	Drug	disease group

Primary outcome

Th17/Treg
Time frame: 4 weeks
Ratio of Th17 to Treg percentages in peripheral blood.

1 secondary outcome

cytokines, inflammatory factor
Time frame: 4 weeks

Results and safety

The study was stopped early (reason given: The study was terminated due to insufficient funding, rendering it impossible to continue purchasing reagents for experiments). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Background: PubMed 36004343Lasa M, Contreras-Jurado C. Thyroid hormones act as modulators of inflammation through their nuclear receptors. Front Endocrinol (Lausanne). 2022 Aug 8;13:937099. doi: 10.3389/fendo.2022.937099. eCollection 2022.
Background: PubMed 9506856Michalopoulou G, Alevizaki M, Piperingos G, Mitsibounas D, Mantzos E, Adamopoulos P, Koutras DA. High serum cholesterol levels in persons with 'high-normal' TSH levels: should one extend the definition of subclinical hypothyroidism? Eur J Endocrinol. 1998 Feb;138(2):141-5. doi: 10.1530/eje.0.1380141.
Background: PubMed 33746942Cayres LCF, de Salis LVV, Rodrigues GSP, Lengert AVH, Biondi APC, Sargentini LDB, Brisotti JL, Gomes E, de Oliveira GLV. Detection of Alterations in the Gut Microbiota and Intestinal Permeability in Patients With Hashimoto Thyroiditis. Front Immunol. 2021 Mar 5;12:579140. doi: 10.3389/fimmu.2021.579140. eCollection 2021.
Background: PubMed 25771887Xue H, Yu X, Ma L, Song S, Li Y, Zhang L, Yang T, Liu H. The possible role of CD4(+)CD25(high)Foxp3(+)/CD4(+)IL-17A(+) cell imbalance in the autoimmunity of patients with Hashimoto thyroiditis. Endocrine. 2015 Dec;50(3):665-73. doi: 10.1007/s12020-015-0569-y. Epub 2015 Mar 13.
Backgroundundefined
Background: PubMed 25861163Xue H, Yang Y, Zhang Y, Song S, Zhang L, Ma L, Yang T, Liu H. Macrophage migration inhibitory factor interacting with Th17 cells may be involved in the pathogenesis of autoimmune damage in Hashimoto's thyroiditis. Mediators Inflamm. 2015;2015:621072. doi: 10.1155/2015/621072. Epub 2015 Mar 15.
Background: PubMed 34983968Lee SY, Pearce EN. Assessment and treatment of thyroid disorders in pregnancy and the postpartum period. Nat Rev Endocrinol. 2022 Mar;18(3):158-171. doi: 10.1038/s41574-021-00604-z. Epub 2022 Jan 4.
Background: PubMed 26064115Yetkin DO, Dogantekin B. The Lipid Parameters and Lipoprotein(a) Excess in Hashimoto Thyroiditis. Int J Endocrinol. 2015;2015:952729. doi: 10.1155/2015/952729. Epub 2015 May 3.
Background: PubMed 29472712Sinha RA, Singh BK, Yen PM. Direct effects of thyroid hormones on hepatic lipid metabolism. Nat Rev Endocrinol. 2018 May;14(5):259-269. doi: 10.1038/nrendo.2018.10. Epub 2018 Feb 23.
Background: PubMed 34519275Kim HJ, Park SJ, Park HK, Byun DW, Suh K, Yoo MH. Thyroid autoimmunity and metabolic syndrome: a nationwide population-based study. Eur J Endocrinol. 2021 Oct 11;185(5):707-715. doi: 10.1530/EJE-21-0634.
Background: PubMed 37810887Ru X, Yang M, Teng Y, Han Y, Hu Y, Wang J, Tao F, Huang K. Association of maternal thyroid peroxidase antibody during pregnancy with placental morphology and inflammatory and oxidative stress responses. Front Endocrinol (Lausanne). 2023 Sep 22;14:1182049. doi: 10.3389/fendo.2023.1182049. eCollection 2023.
Background: PubMed 26405389Mahto M, Chakraborthy B, Gowda SH, Kaur H, Vishnoi G, Lali P. Are hsCRP Levels and LDL/HDL Ratio Better and Early Markers to Unmask Onset of Dyslipidemia and Inflammation in Asymptomatic Subclinical Hypothyroidism? Indian J Clin Biochem. 2012 Jul;27(3):284-9. doi: 10.1007/s12291-012-0206-y. Epub 2012 Apr 18.
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.

Xin Tian principal investigator

Third Affiliated Hospital of Zhengzhou University

Yanjie Ban principal investigator

Third Affiliated Hospital of Zhengzhou University

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Related and Thyroid Stimulating; Hormone, C, run by Third Affiliated Hospital of Zhengzhou University 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jul 2024. 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?

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?

Th17/Treg (time frame: 4 weeks). 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 NCT06527859, which also lists 18 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 30 Jul 2024.