Summary: In 103 fasting adults with hypothyroidism, an extra 25 mcg daily dose of levothyroxine during Ramadan kept the group mean TSH within the reference range (0.55 to 4.78 mIU/L) at all five visits, whereas the standard weight-based dose was associated with a mean TSH above the upper limit at the final two visits (5.15 and 5.15 mIU/L during and after Ramadan). Importantly, mean TSH values were reported as comparable between the two groups, so a statistically significant advantage of the extra dose was not demonstrated.
PICO Summary
| Element | Detail |
|---|---|
| Population | 103 adults with treated hypothyroidism intending to fast during Ramadan; randomized controlled trial, United Arab Emirates. |
| Intervention | An extra fixed dose of 25 mcg levothyroxine taken during Ramadan, without the usual 30-minute pre-meal fasting interval (treatment arm). |
| Comparison | Standard weight-based levothyroxine (1.6 mcg/kg) without dose adjustment during Ramadan (control arm). |
| Outcome | Mean TSH (mIU/L), treatment vs control across five visits: V1 3.00 ± 2.44 vs 3.45 ± 3.02; V2 3.62 ± 3.21 vs 3.74 ± 2.74; V3 4.19 ± 3.85 vs 4.89 ± 2.92; V4 3.54 ± 2.96 vs 5.15 ± 4.26; V5 3.61 ± 3.05 vs 3.32 ± 2.57. The treatment-group mean stayed within range (0.55 to 4.78 mIU/L) at every visit; the control-group mean exceeded the upper limit at visits 4 and 5. Between-group means were reported as comparable; no p value, 95% CI, or ARR/NNT for the primary contrast was provided in the abstract, and no significant adverse effects were reported. |
Extra levothyroxine dose in Ramadan
RCT · hypothyroidism · Ramadan, 5 visits
At the during-Ramadan visit the extra-dose group mean TSH stayed in range (3.54 mIU/L) while the standard-dose group rose above the limit (5.15 mIU/L), but the authors report the groups as comparable with no significance test, so the advantage is suggestive only.
Expert Commentary
This randomized trial addresses a genuine clinical headache: how to keep absorption of levothyroxine reliable when patients eat before dawn and break their fast after sunset, compressing the usual empty-stomach window. The pragmatic answer tested here, simply adding a fixed 25 mcg on top of usual therapy and dropping the pre-meal interval, is attractive because it is easy to explain and cheap to implement. The signal is in the right direction: the treatment-group mean TSH was held inside the reference range throughout, while the control-group mean drifted above it at the during-Ramadan and post-Ramadan visits. The verdict, however, must be measured. The authors themselves report the between-group means as comparable, and the abstract supplies no p value, confidence interval, or number needed to treat for the primary comparison, so superiority of the extra dose is suggested but not statistically established. The most weighing limitation is this absence of a formal between-group inferential test on a modest sample of 103, which leaves the headline open to a chance or regression-to-the-mean explanation, compounded by wide standard deviations. Can I use this with my patients? Cautiously, yes, as a shared-decision option for a stable, weight-eligible hypothyroid patient who cannot manage the dosing interval while fasting, with a post-Ramadan TSH check rather than as a blanket rule. A confirmatory trial reporting the between-group difference with its confidence interval and FT4 would settle the question.
References
Al-Mutawa N, Mussa BM, Akhlaq S, AbdulWahid Z, Qawas A. Extra levothyroxine dose in Ramadan maintained normal thyroid hormone levels in patients with hypothyroidism: a randomized controlled trial. Front Endocrinol (Lausanne). 2025;16:1513904. doi:10.3389/fendo.2025.1513904