Clinical trial NCT06660888: Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals
Official title: Study of Chronic Fatigue, Depression, and Anxiety Among Hypothyroid Patients Attending Assuit University Hospitals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypothyroidism Primary
Keywords: Fatigue
Depression
Anxiety
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary hypothyroidism with age from 18 to 60 years.

Brief summary: * 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of chronic fatigue in patients with hypothyroidism at Assuit University Hospitals.
timeFrame: Baseline
measure: Prevalence of depression in patients with hypothyroidism at Assuit University Hospitals.
timeFrame: Baseline
measure: Prevalence of anxiety in patients with hypothyroidism at Assuit University Hospitals.
timeFrame: Baseline
Secondary outcomes:
measure: Compare the severity of chronic fatigue according to the duration and control of treatment in patients with hypothyroidism.
timeFrame: Baseline
measure: Compare the severity of depression according to the duration and control of treatment in patients with hypothyroidism.
timeFrame: Baseline
measure: Compare the severity of anxiety according to the duration and control of treatment in patients with hypothyroidism.
timeFrame: Baseline
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university hospitals
Study officials:
affiliation: Assiut University
name: Ghada A Elkhateeb, Prof.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Romany H Gabra, A prof.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Dalia G Mohammed, Prof.
role: STUDY_DIRECTOR
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citation: 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.
citation: 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.
citation: 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.