Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals

NCT ID: NCT06660888

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-27

Study Completion Date

2026-12-31

Brief Summary

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* Assessment of the prevalence of chronic fatigue, depression, and anxiety among patients with hypothyroidism in Assuit University Hospital.
* Assess the severity of chronic fatigue, depression, and anxiety according to the duration and control of treatment in patients with hypothyroidism.

Detailed Description

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Hypothyroidism is a prevalent endocrine illness with a global impact, necessitating treatment in extreme instances. Inadequate management of hypothyroidism has been associated with adverse health outcomes, including neurological and musculoskeletal issues,this condition impacting approximately 1-6% of the general population.

Thyroid hormone is essential for the normal development of many human tissues and regulates the metabolism of virtually all cells and organs of the human body throughout life. Overt hypothyroidism is defined by thyroid-stimulating hormone (TSH) levels above the upper limit of the reference range, while levels of free thyroxine (fT4) are below the lower limit of the reference range. The reference range is typically statistically defined by the 2.5th and 97.5th percentiles of the measured circulating thyroid hormone values in populations defined as healthy.

It has been reported that up to one-third of patients presenting with fatigue have thyroid disease, predominantly in women,and fatigue was the most common noted symptom among patients with hypothyroidism.Also patients with thyroid disorders are more prone to developing depressive symptoms.

There are few previous studies that addressed this topic in the Egyptian population.

Conditions

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Hypothyroidism Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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• Fatigue Severity Scale (FFS). • Hamilton Rating Scale for Depression (HRSD-17). • Hamilton Anxiety Rating Scale (HAM-A).

1. Fatigue Severity Scale The FSS is one of the most commonly used fatigue questionnaires in chronic diseases. It measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, work, family, or social life.
2. Hamilton Depression Rating Scale The 17-item Hamilton Depression Rating Scale (HRSD-17) is the most popular depression measure in antidepressant clinical trials.
3. Hamilton Anxiety Rating Scale The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with primary hypothyroidism.
* Age from 18 to 60 years.

Exclusion Criteria

* Patients who were previously diagnosed with any psychiatric diseases.
* Serious and chronic diseases (e.g. anemia, liver, heart or kidney problems).
* consumption of medications that may interfere with thyroid function (e.g., chemotherapy), patients who had a history of any type of cancer, due to the confounding effects of cancer on fatigue as the outcome of interest.
* Women who were pregnant or had given birth in the last 6 months to exclude postpartum thyroiditis and depression.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aya Hamdy Rashed

Resident Doctor at Family Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada A Elkhateeb, Prof.

Role: STUDY_DIRECTOR

Assiut University

Romany H Gabra, A prof.

Role: STUDY_DIRECTOR

Assiut University

Dalia G Mohammed, Prof.

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assuit university hospitals

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

References

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Udovcic M, Pena RH, Patham B, Tabatabai L, Kansara A. Hypothyroidism and the Heart. Methodist Debakey Cardiovasc J. 2017 Apr-Jun;13(2):55-59. doi: 10.14797/mdcj-13-2-55.

Reference Type BACKGROUND
PMID: 28740582 (View on PubMed)

Sethi B, Barua S, Raghavendra MS, Gotur J, Khandelwal D, Vyas U. The Thyroid Registry: Clinical and Hormonal Characteristics of Adult Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2017 Mar-Apr;21(2):302-307. doi: 10.4103/ijem.IJEM_387_16.

Reference Type BACKGROUND
PMID: 28459030 (View on PubMed)

Evans KM, Flanagan DE, Wilkin TJ. Chronic fatigue: is it endocrinology? Clin Med (Lond). 2009 Feb;9(1):34-8. doi: 10.7861/clinmedicine.9-1-34.

Reference Type BACKGROUND
PMID: 19271598 (View on PubMed)

Ruiz-Pacheco MG, Hernandez I, Hernandez-Estrella G, Basurto L, Vargas-Ortega G, Gonzalez-Virla B, Molina-Ayala M, Hernandez-Martinez AF, Luengas-Mondragon R, Hernandez-Allende AA, Mendoza-Zubieta V, Balcazar-Hernandez L. Severity of Fatigue and Its Relationship with TSH before and after Levothyroxine Replacement Therapy in Patients with Primary Hypothyroidism. Biomedicines. 2023 Mar 7;11(3):811. doi: 10.3390/biomedicines11030811.

Reference Type BACKGROUND
PMID: 36979787 (View on PubMed)

Chaker L, Razvi S, Bensenor IM, Azizi F, Pearce EN, Peeters RP. Publisher Correction: Hypothyroidism. Nat Rev Dis Primers. 2022 Jun 10;8(1):39. doi: 10.1038/s41572-022-00373-7. No abstract available.

Reference Type BACKGROUND
PMID: 35688906 (View on PubMed)

Nassar M, Hassan A, Ramadan S, Desouki MT, Hassan MA, Chaudhuri A. Evaluating the effectiveness of combined T4 and T3 therapy or desiccated thyroid versus T4 monotherapy in hypothyroidism: a systematic review and meta-analysis. BMC Endocr Disord. 2024 Jun 14;24(1):90. doi: 10.1186/s12902-024-01612-6.

Reference Type BACKGROUND
PMID: 38877429 (View on PubMed)

Ali ZH, Abdulridha MK, Alzajaji QB. Screening factors affecting proper levothyroxine therapy among patients with primary hypothyroidism: a cross-sectional study. J Med Life. 2024 Feb;17(2):177-187. doi: 10.25122/jml-2023-0387.

Reference Type BACKGROUND
PMID: 38813351 (View on PubMed)

Hage MP, Azar ST. The Link between Thyroid Function and Depression. J Thyroid Res. 2012;2012:590648. doi: 10.1155/2012/590648. Epub 2011 Dec 14.

Reference Type BACKGROUND
PMID: 22220285 (View on PubMed)

Other Identifiers

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Fatigue in Hypothyroidism

Identifier Type: -

Identifier Source: org_study_id

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