A double-blind placebo-controlled trial of liquid thyroxine ingested at breakfast: results of the TICO study
Abstract
BACKGROUND: Levothyroxine (LT4) is the recommended treatment for millions of hypothyroid patients. Current guidelines recommend that LT4 tablets be taken in a fasting state, but inability to adhere to this often leads to poor therapy compliance. METHODS: A randomized, double-blind, placebo-controlled, crossover trial was conducted in previously untreated hypothyroid patients randomly assigned to receive an oral solution of LT4 either at least 30 minutes before breakfast or directly at breakfast time. Each patient completed two six-week treatment periods, with different timing of active LT4 administration: placebo before breakfast and active LT4 at breakfast, or vice versa. At the end of each period, thyrotropin (TSH), free thyroxine (fT4), and free triiodothyronine (fT3) were measured. The primary endpoint was to verify any difference in serum TSH levels whether consuming liquid LT4 at breakfast or 30 minutes prior to breakfast. RESULTS: A total of 77 patients (64 females; median age 45.4 ± 3.7 years) completed the study. No statistically significant differences in serum TSH, fT4, or fT3 levels were observed whether LT4 was taken at breakfast or 30 minutes before, in a fasting state. No significant effect from the sequence of regimens, breakfast composition, and/or concomitantly administered drugs was observed on the dose of LT4 administered, or on the post-treatment serum TSH values. CONCLUSIONS: The TICO study suggests that a liquid LT4 formulation can be ingested directly at breakfast, thus potentially improving therapeutic compliance. This observation is of considerable clinical relevance, since non-adherence to LT4 therapy requirements is more likely to cause variability in serum TSH concentrations.
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Novel LT4 preparations are designed to reduce the high TSH levels induced by malabsorption due to calcium and iron supplements, PPIs, coffee, and breakfast.
“Furthermore, novel LT4 preparations are designed to reduce the high TSH levels induced by malabsorption due to calcium and iron supplements, PPIs, coffee, and breakfast (97–101).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [98]
Only 2 studies were well designed (randomized and crossover).
“Only 2 studies were well designed (randomized and crossover) (11, 98).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [98]
In a 2016 randomized, double-blind, placebo-controlled, crossover trial, 77 patients completed the study at 12 weeks, and no significant differences were observed in FT3, FT4, or TSH, indicating that liquid LT4 can eliminate malabsorption due to coingestion with breakfast.
“Seventy-seven patients completed the study at 12 weeks. No significant differences were observed in FT3, FT4, or TSH, indicating that liquid LT4 can eliminate malabsorption due to coingestion with breakfast.”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [98]
Taken together, the convenience of the liquid preparation improves patient compliance.
“Taken together, these data show that the convenience of the liquid preparation improves patient compliance.”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [98]
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- Authors
- Cappelli, C., Pirola, I., Daffini, L., Formenti, A., Iacobello, C., Cristiano, A., Gandossi, E., Agabiti Rosei, E., & Castellano, M.
- Affiliations
- University of Brescia (IT)
- University of Brescia
- Corresponding author
- Cappelli, Carlo
- Venue
- Thyroid
- Publisher
- SAGE Publications
- Published
- 2016-02
- Volume
- 26
- Issue
- 2
- Pages
- 197-202
- ISSN
- 1050-7256 (ISSN-L)
- 1557-9077
- OpenAlex
- W2175978095
- Cited by
- 80
- References
- 29
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 8 · 2023: 6 · 2022: 9 · 2021: 8 · 2020: 5 · 2019: 7 · 2018: 8 · 2017: 6 · 2016: 11 · 2015: 1
- FWCI
- 7.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Thyroid (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Keywords
- levothyroxine, hypothyroidism, timing of drug administration, breakfast, medication adherence, serum TSH, free thyroxine, free triiodothyronine
- MeSH terms
- Adult, Double-Blind Method, Drug Administration Schedule, Fasting, Female, Humans, Hypothyroidism, Male, Middle Aged, Thyroid Function Tests, Thyrotropin, Thyroxine, Time Factors, Triiodothyronine, Treatment Outcome, Cross-Over Studies, Medication Adherence, Breakfast
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