Hypothyroidism
Conditions
Brief summary
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
Detailed description
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.
Interventions
None listed
Sponsors
Sohag University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All included hypothyrodism patients will be euthyroid, and stable on the same L-T4 dose before the start of study.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome will be the maintenance of euthyroidism,defined as normal thyroid function | 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 | Normal thyroid function, assessed via: TSH: Normal range \[specify, e.g., 0.4-4.0 µIU/mL\] Free T4: Normal range \[specify, e.g., 0.8-1.8 ng/dL\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary outcome 2-Incidence of Adverse Effects - Laboratory Parameters (Complete Blood Count) | 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. | 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 %) |
| secondary outcome. 3- Incidence of Adverse Effects - Laboratory Parameters (Liver Function Tests) | 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. | Incidence of clinical abnormalities Liver Function Tests(e.g., ALT, AST) U/L Unit of Measure: U/L |
| 4-Incidence of Adverse Effects - Laboratory Parameters (Kidney Function Tests) | 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. | Incidence of clinical abnormalities in Kidney Function Tests (e.g., serum creatinine) Unit of Measure: mg/dL |
| . Secondary outcomes will include:-1- the 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) | 1-Incidence of Adverse Effects:\* Clinical parameters: 1. Heart rate (beats per minute) 2. Blood pressure (mmHg) |
| secondary outcome include:-3. Quality of Life (QoL) Assessments using ThyPRO | 1-From Baseline(day 1) until 36 months after enrollment assessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter. | Thyroid-specific QoL measured using validated questionnaires: ThyPRO (Thyroid Patient-Reported Outcome) Unit of Measure: ThyPRO: Scale scores (0-100) |
| Quality of Life (QoL) Assessments - SF-36 | From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter. | chang in general quality of life using SF-36 (Short Form Health Survey) questionnaire. |
| secondary outcome include :-2-Patient Adherence Rates | 1-from baseline(day 1) until 36 months 2-Monthly from Baseline to Week 52 3-- 12 weeks from Week 52 to study completion | 2-Patient Adherence Rates :Measured via self-report, pill counts, or pharmacy refill records. Criteria for adherence (e.g., ≥80% of doses taken). |
Countries
Egypt
Outcome results
None listed