Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2022-03-15
2022-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Mobile Application on Hypothyroid Patients
NCT05708456
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
NCT01102205
Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome
NCT06179368
Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism
NCT01848171
Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients
NCT07133295
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
LT4, which has a narrow therapeutic index, may cause drug-related problems (DRP) such as non-adherence to treatment, the timing of drug use, inappropriate use of the drug, inadequate therapeutic dose, duration of treatment, inadequate monitoring of treatment and potential drug-drug interactions (pDDI). In a study conducted in a hospital in India, DRP encountered during treatment with narrow therapeutic index drugs were compared with DRP encountered with other drugs. It was reported that DRPs were associated with pDDIs, adverse effects, dose overdose, dose underdose, untreated indications, inappropriate drug use, unnecessary drug use, and patient-related factors. In the study in which LT4 was also included, the rate of DRPs to narrow therapeutic index was 22%, and the rate of DRPs to other drugs was reported to be 8%. In a study documenting the interventions of pharmacists in hospitals in Germany, the interventions made between 2009 and 2012 were analyzed; LT4 was one of the ten drugs with the highest number of problems, and half of these problems were drug interactions and the inadequate therapeutic dose in patients with organ failure.
Aluminum hydroxide, bile acid secretagogues, calcium polystyrene sulphonate, sodium polystyrene sulphonate, calcium salts, iron preparations, multivitamin supplements containing iron, lanthanum carbonate, sevelamer, magnesium salts, orlistat, and raloxifene cause D-level drug interactions with LT4. In the concomitant use of calcium salts with LT4, it is observed that LT4 absorption and, consequently, therapeutic effect decreases \[8,9\]. In a systematic review of the concomitant use of LT4 and proton pump inhibitors (PPI) in hypothyroid patients with dyspepsia, gastroesophageal reflux, or peptic ulcer, a statistically significant increase in thyroid-stimulating hormone (TSH) levels was observed.
Since the therapeutic index of the LT4 drug is narrow, it emphasizes the importance of adherence to the drug in reaching ideal TSH levels. Medication adherence is a dynamic process closely linked to treatment outcomes in patients with chronic diseases. Very few studies exist on LT4 treatment and patient adherence to treatment. In their study, Yavuz et al. emphasized that almost half of HoT patients had serum TSH values outside the reference range despite receiving LT4 treatment and that adherence with LT4 treatment was one of the most critical determinants in reaching target TSH levels.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
Group in which only observation is made by the clinical pharmacist For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received levothyroxine treatment for thyroid diseases and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded.
No interventions assigned to this group
Intervention Group
Group to which the clinical pharmacist makes recommendations For patients in this group, intervention (i.e. recommendation) will be made to physician in charge by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received treatment for thyroid diseases and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems.
Clinical Pharmacist Intervention Group
Group to which the clinical pharmacist makes recommendations The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical Pharmacist Intervention Group
Group to which the clinical pharmacist makes recommendations The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients visited the endocrinology diseases outpatient clinic
3. Being 18 years or older.
4. Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.
Exclusion Criteria
2. Lost follow up in 30th day after thyroid disease.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
OTHER
Marmara University
OTHER
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muhammed Yunus Bektay
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marmara University
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ayhan YE, Bektay MY, Gogas Yavuz D, Sancar M. Evaluation of the clinical pharmacist's effect on achieving treatment goals in patients with hypothyroidism: a randomized controlled trial. BMC Endocr Disord. 2025 Apr 8;25(1):94. doi: 10.1186/s12902-025-01914-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pharm. Role Thyorid Disorder
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.