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Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients. A comparative study found that once-weekly L-T4 did not result in significant adverse effects compared to daily dosing, reinforcing its potential as a safe treatment option
Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing. A study published in 2023 demonstrated that once-weekly L-T4 is effective in maintaining euthyroidism in patients with treatment-refractory hypothyroidism.
The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients.
Adherence to treatment is crucial for the management of hypothyroidism, and once-weekly regimens may enhance patient compliance. Studies have shown that patients are more likely to adhere to a once-weekly regimen compared to daily dosing, which can lead to improved clinical outcomes. This is particularly relevant for patients with non-adherence issues, as highlighted in recent literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 patients who will continue to take L-T4 on standard daily basis. | |||
| Group 2 patients who will switch to once weekly dosing |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the maintenance of euthyroidism,defined as normal thyroid function | Normal thyroid function, assessed via: TSH: Normal range [specify, e.g., 0.4-4.0 µIU/mL] Free T4: Normal range [specify, e.g., 0.8-1.8 ng/dL] | From baseline (study enrollment) until 36 months after enrollment. first year :assessments will be conducted 2 months after each dose adjustment in subsequent years assessment conducted quarterly up to end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| . Secondary outcomes will include:-1- the incidence of adverse effects(clinical parameters) | 1-Incidence of Adverse Effects:* Clinical parameters:
| 1-Baseline (Day 1) until 24 months 2-Week 8 (2 months post-initial dose adjustment) 3-Every 12 weeks (±7 days) thereafter until study completion (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
-1- patients with thyroid cancer patients requiring suppressive therapy 2-patients with central hypothyroidism 3- pregnancy, coronary heart disease, arrythmia, chronic heart failure 4-patients with liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non-thyroidal illness syndromes.
4- Patients taking any medications known to interfere with levothyroxine absorption or metabolism (calcium and iron supplements, antiepileptic agents, antacids, proton pump inhibitors, and H2blockers)
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This a prospective randomized conducted over three years will be including hypothyroid patients attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.
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| Name | Affiliation | Role |
|---|---|---|
| sara Kasem Abdelal, lecturer | sohag university .faculty of medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| sohag faculty of medicine, Sohag | Sohag | Egypt |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| secondary outcome 2-Incidence of Adverse Effects - Laboratory Parameters (Complete Blood Count) | Incidence of clinically significant abnormalities in Complete Blood Count Unit of Measure: (e.g., cell counts in cells/µL, hemoglobin in g/dL, hematocrit in %) | From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter. |
| secondary outcome. 3- Incidence of Adverse Effects - Laboratory Parameters (Liver Function Tests) | Incidence of clinical abnormalities Liver Function Tests(e.g., ALT, AST) U/L Unit of Measure: U/L | From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter. |
| 4-Incidence of Adverse Effects - Laboratory Parameters (Kidney Function Tests) | Incidence of clinical abnormalities in Kidney Function Tests (e.g., serum creatinine) Unit of Measure: mg/dL | From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter. |
| secondary outcome include :-2-Patient Adherence Rates | 2-Patient Adherence Rates :Measured via self-report, pill counts, or pharmacy refill records. Criteria for adherence (e.g., ≥80% of doses taken). | 1-from baseline(day 1) until 36 months 2-Monthly from Baseline to Week 52 3-- 12 weeks from Week 52 to study completion |
| secondary outcome include:-3. Quality of Life (QoL) Assessments using ThyPRO | Thyroid-specific QoL measured using validated questionnaires: ThyPRO (Thyroid Patient-Reported Outcome) Unit of Measure: ThyPRO: Scale scores (0-100) | 1-From Baseline(day 1) until 36 months after enrollment assessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter. |
| Quality of Life (QoL) Assessments - SF-36 | chang in general quality of life using SF-36 (Short Form Health Survey) questionnaire. | From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter. |