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NCT07408765
Background. Primary hypothyroidism, both clinical and subclinical, is frequently associated with persistent fatigue, reduced psychological well-being, and lower levels of physical activity in adult women. However, evidence integrating these psychosocial factors remains limited and methodologically heterogeneous. Objective. To analyze the association between physical activity and fatigue, social support, and psychological well-being in women with primary hypothyroidism; to compare these profiles between clinical and subclinical hypothyroidism; and to explore the moderating effect of social support and psychological well-being on the relationship between fatigue and physical activity. Methods. An observational, analytical, multicenter cohort study will be conducted including 96 adult women with primary hypothyroidism from the Principality of Asturias. Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while fatigue, social support, and psychological well-being will be measured using the Fatigue Severity Scale (FSS), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the WHO-5 Well-Being Index, respectively. Confounding variables will include age, body mass index, type of hypothyroidism (clinical or subclinical), and time since diagnosis. Descriptive analyses, comparisons between clinical and subclinical groups, and multiple linear regression models will be performed. Expected results. The study is expected to identify physical activity levels within the sample and determine which psychosocial factors are independently associated with physical activity. Additionally, fatigue is anticipated to be negatively associated with physical activity, whereas social support and psychological well-being are expected to show positive associations and potential moderating effects.
NCT06276205
The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment. The main question it aims to answer is: • whether adding Vitamin D to standard therapy has any additional benefits Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine. Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them
NCT04988802
Hypothyroidism is a common disease that is successfully treated with the replacement of thyroid hormones in the form of levothyroxine. Levothyroxine is drug used in the first line of substitution therapy because it appropriately mimics physiological secretion of thyroxine (T4) and its peripheral conversion to triiodothyronine (T3). However, due to its narrow therapeutic index, and because it is administered at very low doses (micrograms - μg), it is particularly sensitive to the absorption phase interactions, which are due to its narrow therapeutic index, mainly clinically significant. In pregnancy, one of the goals is to maintain the values of thyroid stimulating hormone (TSH) in the lower part of the reference interval (below 2,5 milli-International units - mIU/L) for a proper child development. Also, due to increased nutritional needs during pregnancy, nutritional supplements are commonly used by pregnant women on their own initiative, but also often recommended by healthcare personnel. Reviewing the literature, we did not find high quality evidence to suggest the existence or to refute the interaction between dietary supplements for pregnant women and the absorption of levothyroxine. The aim of this study is to investigate this potential interaction between dietary supplements used in pregnancy and levothyroxine absorption in order to test the safety of the use of these preparations in pregnant women who are on replacement therapy with levothyroxine.