Hashimoto's Thyroiditis Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants are randomised using an online system to receive either Mycophenolate Mofetil (MMF) tablets or matched placebo (“dummy” tablets). Participants will be randomised in a 5:3 ratio (30 partic
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients =18yrs and =50yrs old 2. Hashimoto thyroiditis with at least one documented serum TSH =7.0 mU/L 3. Current positive thyroid peroxidase antibodies (TPOAb =34 U/L) 4. Serum TSH currently within reference range 5. On stable dose of levothyroxine for at least 3 months 6. Persistent fatigue as judged FACIT-F score =7 and =35 7. For women of child-bearing potential (WOCBP), willing to use a highly effective contraceptive method during their participation in the trial 8. Able to understand and complete trial procedures (with translation or verbal explanation if required). 9. Willing and able to provide informed consent prior to any trial procedures taking place
Exclusion criteria
Exclusion criteria: 1. Previous thyroidectomy or radioiodine treatment 2. Pregnant or breastfeeding, or with a plan for pregnancy within 6 months; unwillingness to undergo regular pregnancy testing. 3. Hepatitis B & C or HIV infection 4. Anaemia (Hb = 115g/l), thrombocytopenia (=75 x10^9/L) or neutropenia (=1.0 x10^9/L), abnormal ferritin, vitamin D (10 9. Consumes more than 20 units of alcohol per week 10. Current use of medication that would interfere with mycophenolate action, including proton pump inhibitors. 11. Current use of medication that precludes thyroid FNA including warfarin and DOACs 12. Current use of immunosuppressive therapy for other conditions (within 3 months) 13. Current or previous participation in a CTIMP or intervetional research study within 3 months 14. Hypersensitivity or anaphylactic reaction to mycophenolate mofetil or mycophenolic acid 15. Inability, in the opinion of the investigator, to be able to complete the clinical trial visits or procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in numbers of CD45+ thyroid lymphocytes assayed by flow cytometry (baseline to 16 weeks) assayed from thyroid cellular aspirates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in FACIT-F, ThyPRO39, SF-36, GHQ-12, and POMS2 scores (baseline to 8 and 16 weeks). 2. Correlation of changes in FACIT-F, ThyPRO39, SF-36, GHQ-12, and POMS2 scores with changes in the number of thyroid lymphocytes (baseline to 16 weeks). 3. Change in thyroid SUVmax during 18FDG-FDG PET/CT scanning (baseline to 16 weeks). 4. Change in serum TPOAb, TgAb, hsCRP, procalcitonin, ESR, and neutrophil-to-lymphocyte ratio (baseline to 8 and 16 weeks). 5. Change in numbers of CD4, CD8, CD19, and other thyroid lymphocyte subsets assayed by flow cytometry (baseline to 16 weeks). 6. Change in TSH, FT4, and FT3 (baseline to 8 and 16 weeks). 7. Change in cognitive function tests: digit-span, trail making, complex figure, and pinboard tests (baseline to 8 and 16 weeks). 8. Correlation of changes in FACIT-F, ThyPRO39, SF-36, GHQ-12, PSQI, POMS2, and WHO-5 scores with serum TPOAb, hsCRP, and other inflammatory markers (baseline to 16 weeks). 9. Change in serum liver function and blood count parameters (baseline to 8 and 16 weeks). 10. Adverse reactions up to 16 weeks. 11. Change in Levothyroxine dose. 12. Change in FACIT-F score at week 22. | — |
Countries
United Kingdom
Contacts
Public Contact. Study Team
Outcome results
None listed