Subclinical Hypothyroidism Clinical Trial
— DANTIANOfficial title:
Dietary Intervention With Únicla Dairy Products, Naturally Enriched With Selenium and Omega-3 Fatty Acids, May Improve Thyroid-stimulating Hormone (TSH) Levels in Women With Subclinical Hypothyroidism
Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | May 30, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 65 Years |
Eligibility | 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 ?-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 |
Country | Name | City | State |
---|---|---|---|
Spain | Nursing University School of Ourense | Ourense |
Lead Sponsor | Collaborator |
---|---|
Cooperativas Lacteas Unidas | Galician South Health Research Institute |
Spain,
Muñiz-Naveiro O, Domínguez-González R, Bermejo-Barrera A, Cocho de Juan JA, Fraga Bermúdez JM, Goris Pereiras A, López Santamariña A, Martínez Lede I, Valledor Puente J, Fernández-Couto Gómez L, Bermejo-Barrera P. Selenium content and distribution in cow's milk supplemented with two dietary selenium sources. J Agric Food Chem. 2005 Dec 14;53(25):9817-22. — View Citation
Roibás L, Martínez I, Goris A, Barreiro R, Hospido A. An analysis on how switching to a more balanced and naturally improved milk would affect consumer health and the environment. Sci Total Environ. 2016 Oct 1;566-567:685-697. doi: 10.1016/j.scitotenv.2016.05.141. Epub 2016 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with changes in thyroid function | thyroid stimulating hormone blood level | 3 months | |
Secondary | HDL level | high density lipoproteins blood level | 3 months | |
Secondary | selenium | selenium blood level | 3 months | |
Secondary | IL-6 | Interleukina-6 blood level | 3 months | |
Secondary | Fecal calprotectin | Fecal calprotectin feces level | 3 months |
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