HypothyroidismNCT05143918
Quality of Life Among Egyptian Hypothyroid Patients
An observational study of Hypothyroidism, run by Assiut University.
Trial summary
Assessment of quality of life among hypothyroid patients in Assiut University Hospital Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- assessment of quality of life using questionnaire
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 30 Dec 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cases as hypothyroid patients and healthy control
Who may be able to join
- age ranges will be 18 - 60 years
- both genders
- previously confirmed diagnosed
Who cannot join
- pregnancy
- other comorbidities (hypertension, diabetes, malignancy,,,etc)
Trial locations and contacts
No sites are listed yet.
Ghada Abd El Rahman contact
About this study
Official title: Assessment of Quality of Life Among Hypothyroid Patients in Assiut University Hospitals
Assessment of quality of life among hypothyroid patients in Assiut University Hospital
Read the detailed description
Hypothyroidism is an underactive thyroid gland. Hypothyroidism means that the thyroid gland can't make enough thyroid hormone to keep the body running normally. People are hypothyroid if they have too little thyroid hormone in the blood. Common causes are Iodine deficiency, autoimmune disease, such as Hashimoto's thyroiditis, surgical removal of the thyroid, and radiation treatment.
There are three types of hypothyroidism: primary, secondary and tertiary. Primary hypothyroidism results from a low level of thyroid hormone due to destruction of the thyroid gland. This condition results in increased secretion and elevation of serum thyroid-stimulating hormone (TSH) levels. If the structure of the gland remains normal, dysfunction can be caused by decreased TSH secretion from the pituitary; this Is called secondary hypothyroidism.
In tertiary hypothyroidism, a decrease in thyroid hormone arises from inadequate secretion of thyrotropin-releasing hormone (TRH) from the hypothalamus. It is not always possible to differentiate between secondary and tertiary hypothyroidism, and they are often collectively referred to as central hypothyroidism. About 99%ofhypothyroidism cases are primary hypothyroidism.
Hypothyroidism is common throughout the world. In iodine-sufficient countries, the prevalence of hypothyroidism ranges from 1% to 2%. rising to 7% in individuals aged between 85 and 89 years. In the absence of age-specific reference ranges for TSH, an ageing population is likely to result in a higher prevalence of hypothyroidism. Hypothyroidism is approximately ten times more prevalent in women than men10. the awareness of hypothyroidism has increased gradually, as has rate of initiation of levothyroxine substitution.
Symptoms usually develop slowly and the patient may not realise to have a medical problem for several years. Common symptoms include: tiredness, being sensitive to cold, weight gain, constipation, depression, slow movements and thoughts, muscle aches and weakness, muscle cramps, dry and scaly skin, brittle hair and nails, loss of libido (sex drive), pain, numbness and a tingling sensation in the hand and fingers (carpal tunnel syndrome),irregular periods or heavy periods.
Health-related quality of life (HRQL) is a subjective assessment of the effects of disease and its treatment on the physical, social, psychological, and somatic dimensions of a patient's life. Thus, HRQL is considered an important supplementary outcome measure in the management of different conditions.
Thyroid hormones are important for the body's total energy metabolism and the neuroendocrine function. Hence, it seems apparent that a dysfunction of the thyroid hormone secretion should have a major influence on the total capacity of the body, both physically and mentally. Increasing attention is being paid to assessing HRQL among patients with thyroid disorders, and previous studies have revealed that HRQL is frequently affected in patients with hypothyroidism.
Up to our knowledge, no previous study explored the quality of life and its correlates among Egyptian hypothyroidism patients. The current study aims to assess the quality of life and its predictor among hypothyroidism in Assiut University Hospital
- Conditions
- Hypothyroidism
- Being tested
- assessment of quality of life using questionnaire
- Keywords
- Hypothyroidism, Egypt, Quality of life
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of quality of life using questionnaireOther
assessment of quality of life in hypothyroid patients using SF 36 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroid patients as a cases | 1. Inclusion criteria:
1. age ranges will be 18 - 60 years
2. both genders
3. previously confirmed diagnosed
2. Exclusion criteria:
1. pregnancy
2. other comorbidities (hypertension, diabetes, malignancy,,,etc) Receives: Other: assessment of quality of life using questionnaire | |
| Control group | Healthy people without chronic disease Receives: Other: assessment of quality of life using questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of quality of life among hypothyroid patients
Using the Short Form (36) Health Survey (SF-36) questionnaire all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100.
Measured: nearly two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start31 Dec 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Fathy Radwan Abd El Zaher, Assiut University
- Investigators
- Nabawia M Tawfik, Study chair, Assiut UniversityGhada Abd El Rahman, Study director, Assiut UniversityDoaa M Osman, Study director, Assiut UniversityNoha F Radwan, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143918
- Sponsor's protocol ID
- quality of life
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shivaprasad C, Rakesh B, Anish K, Annie P, Amit G, Dwarakanath CS. Impairment of Health-related Quality of Life among Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2018 May-Jun;22(3):335-338. doi: 10.4103/ijem.IJEM_702_17.
PubMed 30090724Blazewicz A, Wisniewska P, Skorzynska-Dziduszko K. Selected Essential and Toxic Chemical Elements in Hypothyroidism-A Literature Review (2001-2021). Int J Mol Sci. 2021 Sep 20;22(18):10147. doi: 10.3390/ijms221810147.
PubMed 34576309Taylor PN, Albrecht D, Scholz A, Gutierrez-Buey G, Lazarus JH, Dayan CM, Okosieme OE. Global epidemiology of hyperthyroidism and hypothyroidism. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo.2018.18. Epub 2018 Mar 23.
PubMed 29569622Mitchell AL, Hegedus L, Zarkovic M, Hickey JL, Perros P. Patient satisfaction and quality of life in hypothyroidism: An online survey by the british thyroid foundation. Clin Endocrinol (Oxf). 2021 Mar;94(3):513-520. doi: 10.1111/cen.14340. Epub 2020 Dec 17.
PubMed 32978985
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life Among Hypothyroid Patients in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05143918
- Acronym / sponsor ID
- quality of life
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism, Egypt, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 Dec 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.
Assessment of quality of life among hypothyroid patients in Assiut University Hospital
Detailed description
Hypothyroidism is an underactive thyroid gland. Hypothyroidism means that the thyroid gland can't make enough thyroid hormone to keep the body running normally. People are hypothyroid if they have too little thyroid hormone in the blood. Common causes are Iodine deficiency, autoimmune disease, such as Hashimoto's thyroiditis, surgical removal of the thyroid, and radiation treatment.
There are three types of hypothyroidism: primary, secondary and tertiary. Primary hypothyroidism results from a low level of thyroid hormone due to destruction of the thyroid gland. This condition results in increased secretion and elevation of serum thyroid-stimulating hormone (TSH) levels. If the structure of the gland remains normal, dysfunction can be caused by decreased TSH secretion from the pituitary; this Is called secondary hypothyroidism.
In tertiary hypothyroidism, a decrease in thyroid hormone arises from inadequate secretion of thyrotropin-releasing hormone (TRH) from the hypothalamus. It is not always possible to differentiate between secondary and tertiary hypothyroidism, and they are often collectively referred to as central hypothyroidism. About 99%ofhypothyroidism cases are primary hypothyroidism.
Hypothyroidism is common throughout the world. In iodine-sufficient countries, the prevalence of hypothyroidism ranges from 1% to 2%. rising to 7% in individuals aged between 85 and 89 years. In the absence of age-specific reference ranges for TSH, an ageing population is likely to result in a higher prevalence of hypothyroidism. Hypothyroidism is approximately ten times more prevalent in women than men10. the awareness of hypothyroidism has increased gradually, as has rate of initiation of levothyroxine substitution.
Symptoms usually develop slowly and the patient may not realise to have a medical problem for several years. Common symptoms include: tiredness, being sensitive to cold, weight gain, constipation, depression, slow movements and thoughts, muscle aches and weakness, muscle cramps, dry and scaly skin, brittle hair and nails, loss of libido (sex drive), pain, numbness and a tingling sensation in the hand and fingers (carpal tunnel syndrome),irregular periods or heavy periods.
Health-related quality of life (HRQL) is a subjective assessment of the effects of disease and its treatment on the physical, social, psychological, and somatic dimensions of a patient's life. Thus, HRQL is considered an important supplementary outcome measure in the management of different conditions.
Thyroid hormones are important for the body's total energy metabolism and the neuroendocrine function. Hence, it seems apparent that a dysfunction of the thyroid hormone secretion should have a major influence on the total capacity of the body, both physically and mentally. Increasing attention is being paid to assessing HRQL among patients with thyroid disorders, and previous studies have revealed that HRQL is frequently affected in patients with hypothyroidism.
Up to our knowledge, no previous study explored the quality of life and its correlates among Egyptian hypothyroidism patients. The current study aims to assess the quality of life and its predictor among hypothyroidism in Assiut University Hospital
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothyroid patients as a cases | – | Other: assessment of quality of life using questionnaire1. Inclusion criteria: 1. age ranges will be 18 - 60 years 2. both genders 3. previously confirmed diagnosed 2. Exclusion criteria: 1. pregnancy 2. other comorbidities (hypertension, diabetes, malignancy,,,etc) |
| Control group | – | Other: assessment of quality of life using questionnaireHealthy people without chronic disease |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cases as hypothyroid patients and healthy control
Key inclusion criteria (3 listed)
- age ranges will be 18 - 60 years
- both genders
- previously confirmed diagnosed
Key exclusion criteria (2 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 |
|---|---|---|
| assessment of quality of life using questionnaireassessment of quality of life in hypothyroid patients using SF 36 questionnaire | Other | Control group, Hypothyroid patients as a cases |
Primary outcome
predictors of quality of life among hypothyroid patients
Time frame: nearly two year
Using the Short Form (36) Health Survey (SF-36) questionnaire all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 30090724Shivaprasad C, Rakesh B, Anish K, Annie P, Amit G, Dwarakanath CS. Impairment of Health-related Quality of Life among Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2018 May-Jun;22(3):335-338. doi: 10.4103/ijem.IJEM_702_17.
- Background: PubMed 34576309Blazewicz A, Wisniewska P, Skorzynska-Dziduszko K. Selected Essential and Toxic Chemical Elements in Hypothyroidism-A Literature Review (2001-2021). Int J Mol Sci. 2021 Sep 20;22(18):10147. doi: 10.3390/ijms221810147.
- Background: PubMed 29569622Taylor PN, Albrecht D, Scholz A, Gutierrez-Buey G, Lazarus JH, Dayan CM, Okosieme OE. Global epidemiology of hyperthyroidism and hypothyroidism. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo.2018.18. Epub 2018 Mar 23.
- Results publication: PubMed 32978985Mitchell AL, Hegedus L, Zarkovic M, Hickey JL, Perros P. Patient satisfaction and quality of life in hypothyroidism: An online survey by the british thyroid foundation. Clin Endocrinol (Oxf). 2021 Mar;94(3):513-520. doi: 10.1111/cen.14340. Epub 2020 Dec 17.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ghada Abd El Rahman contact
Nabawia M Tawfik study chair
Assiut University
Ghada Abd El Rahman study director
Assiut University
Doaa M Osman study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha F Radwan (01007312012, nohafathy154731994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of quality of life among hypothyroid patients (time frame: nearly two year). 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 NCT05143918, which also lists 4 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 20 Dec 2021.