Trial · NCT07879690
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in serum anti-thyroid peroxidase (anti-TPO) antibody levels | Baseline (month 0) and month 12 | Serum anti-TPO antibodies (IU/mL) measured by immunoassay in a fasting morning blood sample. Change from baseline to month 12 is compared between groups. |
| Secondary | Change in serum anti-thyroglobulin (anti-Tg) antibody levels | Baseline, month 4, month 8 and month 12 | Serum anti-Tg antibodies (IU/mL) measured by immunoassay. |
| Secondary | Change in high-sensitivity C-reactive protein (hs-CRP) | Baseline, month 4, month 8 and month 12 | Serum hs-CRP (mg/L) measured by immunoturbidimetry or nephelometry. |
| Secondary | Change in erythrocyte sedimentation rate (ESR) | Baseline, month 4, month 8 and month 12 | ESR (mm/h) measured by the Westergren method. |
| Secondary | Change in fecal zonulin | Baseline, month 4, month 8 and month 12 | Fecal zonulin measured by ELISA in a stool sample, as a marker of intestinal permeability. |
| Secondary | Change in thyroid function (TSH, free T4 and free T3) | Baseline, month 4, month 8 and month 12 | Serum TSH, free T4 and free T3 measured by immunoassay. |
| Secondary | Change in micronutrient status (25-hydroxyvitamin D, ferritin and selenium) | Baseline, month 4, month 8 and month 12 | Serum 25-hydroxyvitamin D, ferritin and selenium. |
| Secondary | Change in fatigue (Fatigue Severity Scale) | Monthly from baseline to month 12 | FSS: 9 items scored 1 to 7; total score is the mean of items (range 1-7). Higher scores indicate more fatigue. |
| Secondary | Change in anxiety and depression (Hospital Anxiety and Depression Scale) | Monthly from baseline to month 12 | HADS: 14 items; anxiety and depression subscales each range 0-21. Higher scores indicate worse symptoms. |
| Secondary | Change in health-related quality of life (WHOQOL-BREF) | Monthly from baseline to month 12 | WHOQOL-BREF: 26 items across physical, psychological, social and environmental domains. Higher scores indicate better quality of life. |
| Secondary | Change in gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale) | Monthly from baseline to month 12 | GSRS: 15 items scored 1 to 7 across 5 symptom dimensions. Higher scores indicate worse symptoms. |
| Secondary | Change in weight | Monthly from baseline to month 12 | Weight (kg) measured with standard anthropometric techniques. |
| Secondary | Change in body mass index | Monthly from baseline to month 12 | Weight and height, measured with standard anthropometric techniques, will be combined to report Body Mass Index in kg/m\^2 . |
| Secondary | Change in waist circumference | Monthly from baseline to month 12 | Waist circumference (cm) measured with standard anthropometric techniques. |
| Secondary | Dietary adherence (Nutritional Adherence Index) | Monthly from baseline to month 12 | Percentage of days with full compliance with the assigned diet, calculated from monthly dietary records. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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