Trial reportThe Journal of clinical endocrinology and metabolism2026
Fasting vs Nonfasting, Dose-adjusted Levothyroxine Ingestion in Hypothyroidism: A Randomized Clinical Trial.
Trial report in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLevothyroxine (LT4) is recommended for intake in a fasting state to optimize absorption. However, fasting intake is often burdensome and may reduce adherence. In a previous questionnaire study, we observed a strong patient preference for taking LT4 with breakfast. Therefore, we conducted a randomized controlled trial to evaluate whether nonfasting LT4 intake-accompanied by a 15% dose increase-could maintain TSH stability compared to fasting LT4 intake.
methodsAdults with well-controlled hypothyroidism were randomized to fasting or dose-adjusted, breakfast LT4 intake. TSH, free T4, and total T3 were measured every 6 weeks, followed by LT4 dose adjustment if needed. The primary outcome was TSH stability, defined as 2 consecutive values within the reference range and a maximum ±1 mIU/L change from baseline. Patients were followed until TSH stability was reached, with a maximum of 24 weeks. After the initial study period, patients in the fasting group were invited to cross over to nonfasting intake, with similar follow-up.
resultsEighty-eight patients (80.7% female, median age 62y [interquartile range: 49-69]) were randomized to fasting (n = 43) or breakfast intake (n = 45). TSH stability was comparable between groups: 74.4% [95% confidence interval (CI): 61.0-88.0%] in the fasting vs 73.3% (95%CI: 60.0-87.0%) in the breakfast group (P = not significant). Similar findings were observed in the crossover group. The breakfast group reported greater improvement in self-reported well-being (33.3% vs 16.3%, P = .07) and a stronger preference for nonfasting intake (76.2% vs 44.2%, P < .001). By the end of the study, 88.9% chose to continue nonfasting intake.
conclusionLT4 ingestion with breakfast with a 15% dose increase maintained TSH stability and improved patient well-being. Given the strong patient preference, this patient-centered approach may offer a viable alternative to fasting administration.
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