UnknownNot Applicable

Dietary Intervention With Únicla Dairy Products (DANTIAN)

Spain90 participantsStarted 2021-09-06

Plain-language summary

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

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of patients with changes in thyroid function

Timeframe: 3 months

Trial details

NCT IDNCT05019118

SponsorCooperativas Lacteas Unidas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-30

Contact for this trial

María Reyes Pérez-Fernández, PhD

676520946 Maria.Reyes.Perez.Fernandez@sergas.es

View on ClinicalTrials.gov More Subclinical Hypothyroidism trials