An interventional study of timing of receiving the drug in Hypothyroidism, sponsored by Hamad Medical Corporation. Completed at 1 site in Qatar. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Treatment
Muslims all over the world fast during the month of Ramadan from dawn until dusk. There is little data regarding the best timing of levothyroxine intake during the month of Ramadan where taking it on an empty stomach represents a challenge to most patients.This study aims to compare two-time points of levothyroxine intake during Ramadan in terms of change in thyroid stimulating hormone (TSH), compliance and convenience.
Hypothyroidism requires regular replacement with levothyroxine to achieve euthyroidism (thyroid hormone status within the normal range). Usually, levothyroxine is taken orally in the morning on a daily basis. In clinical practice, the investigators have observed that this levothyroxine replacement is sub-optimal resulting in higher levels of thyroid stimulating hormone. Based on this observation, the investigators conducted this study to examine whether timing of oral intake of levothyroxine during the holy month of Ramadan will affect achievement of euthyroidism. They recruited 96 hypothyroid patients taking levothyroxine, attending Hamad endocrine outpatient clinics, who were fasting during Ramadan( May-June 2017)and for whom there is no clinical contraindication to fasting. Patients were randomly assigned to two time points for taking levothyroxine:
A. 30 minutes before the Iftar meal B. 30 minutes before Suhour The primary outcome was the change in thyroid stimulating hormone (TSH) before and after Ramadan. The null hypothesis is that there is no difference in TSH between the two groups.
The findings from the study will help in the clinical care of patients with hypothyroidism in Ramadan. Hypothyroidism is common worldwide and many Muslims will require the appropriate advice regarding management of hypothyroidism in Ramadan.
247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's enrollment of 106 is above the median of 78 across 128 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)
Other: timing of receiving the drug
Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)
Other: timing of receiving the drug
each group took levothyroxine in different timing
Change in TSH level
To evaluate the change in TSH level before and after Ramadan in the two groups.
Time frame: 1 month
convenience and compliance
To determine in each group if the timing of levothyroxine dose was convenient and check the compliance with instructions to take levothyroxine in the assigned time. Done through clinical interview
Time frame: 1 month
Plan to share: No — No plan to share individual participant data, but can provide them for researchers who ask for it
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Hamad Medical Corporation