Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT05019118
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of subclinical hypothyroidism
* TSH levels between 3 and 10 mIU / L
* Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)
* Without previous or current treatment with levothyroxine
Exclusion Criteria:
* Thyroid surgery or reception of radioactive iodine in a previous period of 12 months
* History of cardiovascular disease and / or thrombosis
* Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes
* Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)
* Statin treatment and / or hormone replacement therapy
* Adjuvant treatment with trace elements, vitamins or antidepressant and antipsychotic drugs
* Hospitalization for serious illness or elective surgery in the past 4 weeks
* Diseases and / or treatments that affect intestinal absorption (proton pump inhibitors)
* Pregnant, planning to become pregnant or breastfeeding women
* Consumption of ω-3 PUFA type food supplements
* Intolerance and / or allergy to lactose and / or cow's milk proteins
* Any pathology that requires close control, advises against their participation or there is an inability to move independently
* Habitual residence outside the study's influence area
* Participation in another clinical trial with drugs, or in other experimental studies
* Refuse to sign the informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05019118
Study Brief:
Protocol Section:
NCT05019118