Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals
NCT ID: NCT06660888
Last Updated: 2025-02-04
Study Results
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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ENROLLING_BY_INVITATION
406 participants
OBSERVATIONAL
2025-01-27
2026-12-31
Brief Summary
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* Assess the severity of chronic fatigue, depression, and anxiety according to the duration and control of treatment in patients with hypothyroidism.
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Detailed Description
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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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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 60 years.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Aya Hamdy Rashed
Resident Doctor at Family Medicine Department
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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Fatigue in Hypothyroidism
Identifier Type: -
Identifier Source: org_study_id
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