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.
Study Type
OBSERVATIONAL
Enrollment
160
sohag faculty of medicine, Sohag
Sohag, Egypt
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 \[specify, e.g., 0.8-1.8 ng/dL\]
Time frame: 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
. Secondary outcomes will include:-1- the incidence of adverse effects(clinical parameters)
1-Incidence of Adverse Effects:\* Clinical parameters: 1. Heart rate (beats per minute) 2. Blood pressure (mmHg)
Time frame: 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)
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 %)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.