Levothyroxine treatment during Ramadan
| ISRCTN | ISRCTN54141719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54141719 |
- Submission date
- 13/02/2021
- Registration date
- 17/02/2021
- Last edited
- 22/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Hypothyroidism occurs when the body doesn't produce enough thyroid hormones. The researchers have previously shown that plasma (blood) thyroid-stimulating hormone (TSH) rises significantly after Ramadan in levothyroxine-treated hypothyroid patients, possibly as a result of lifestyle alterations and time restrictions during the non-fasting period from dusk until dawn. The aim of this study is to determine the best time to take levothyroxine during Ramadan so as to minimize changes in thyroid function tests during this period.
Who can participate?
Patients aged 18 or over with an underactive thyroid gland (hypothyroidism) who have been on thyroid hormone replacement therapy (levothyroxine) for 6 or more months and are planning to fast during Ramadan 2019
What does the study involve?
Participants are randomly allocated to take levothyroxine at one of the following three times during Ramadan: (group 1) at dusk 30 minutes before Iftar meal, (group 2) 3 or more hours after Iftar meal, or (group 3) at dawn 30 minutes before Suhur meal. Thyroid function tests are performed within 3 months before Ramadan and within 6-weeks after Ramadan.
What are the possible benefits and risks of participating?
There are no anticipated benefits or risks for participation in this study.
Where is the study run from?
Cleveland Clinic Abu Dhabi (United Arab Emirates)
When is the study starting and how long is it expected to run for?
March 2018 to July 2019
Who is funding the study?
1. Investigator initiated and funded
2. Roche Diagnostics provided test kits for plasma TSH and Free-T4
Who is the main contact?
Dr Samer El-Kaissi
elkaiss@clevelandclinicabudhabi.ae
Contact information
Scientific
Cleveland Clinic Abu Dhabi
Abu Dhabi
Abu Dhabi
United Arab Emirates
| Phone | +971 (0)2 501 9000 |
|---|---|
| elkaiss@clevelandclinicabudhabi.ae |
Public
Cleveland Clinic Abu Dhabi
Abu Dhabi
Abu Dhabi
United Arab Emirates
| Phone | +971 (0)2 501 9000 |
|---|---|
| elkaiss@clevelandclinicabudhabi.ae |
Study information
| Study design | Single-center interventional prospective randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Levothyroxine treatment during Ramadan: a prospective study |
| Study acronym | Levo-Ramadan |
| Study objectives | This study aims to determine the best time for taking levothyroxine during Ramadan so as to minimize changes in thyroid function tests during this period. |
| Ethics approval(s) | Approved 17/04/2019, Cleveland Clinic Abu Dhabi Research Ethics Committee (Cleveland Clinic Abu Dhabi, PO Box 112412, Abu Dhabi, UAE; +971 (0)2 501 9000; REC@clevelandclinicabudhabi.ae), ref: A2019-023 |
| Health condition(s) or problem(s) studied | Hypothyroidism |
| Intervention | In a randomized prospective design, hypothyroid patients taking levothyroxine are randomized to take levothyroxine at one of the following three times during Ramadan: (group 1) at dusk 30 minutes before Iftar meal, (group 2) 3 or more hours after Iftar meal, or (group 3) at dawn 30 minutes before Suhur meal. For groups (2) and (3), patients are instructed to allow a minimum of 3 hours between the last meal and levothyroxine and to refrain from eating and drinking for at least 30 minutes after taking levothyroxine. Levothyroxine administration instructions are provided verbally by telephone and a text message is sent to all patients midway through Ramadan as a reminder to adhere to the instructions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levothyroxine |
| Primary outcome measure | Thyroid function tests (plasma TSH and free-T4) measured on the Roche e601 immunoassay analyzer using the electrochemiluminescence immunoassay (ECLIA) sandwich principle for TSH and the ECLIA competition principle for free-T4, within 3 months before Ramadan and repeated within 6 weeks post-Ramadan |
| Secondary outcome measures | 1. The impact of age and gender on the primary outcome measure, change in thyroid function tests (see above) from pre-to post-Ramadan 2. Patient compliance and satisfaction with the assigned randomized treatment assessed with a telephone call to each patient at the end of the study |
| Overall study start date | 30/03/2018 |
| Completion date | 15/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 (50 patients in each arm of the study) |
| Total final enrolment | 148 |
| Key inclusion criteria | 1. Age 18 years or older 2. Hypothyroidism treated with levothyroxine for over 6 months 3. Planning to fast during the month of Ramadan 3. Ability to provide informed consent |
| Key exclusion criteria | 1. Age less than 18 years 2. Inability to provide an informed consent |
| Date of first enrolment | 23/04/2019 |
| Date of final enrolment | 04/05/2019 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centre
Abu Dhabi
AD
United Arab Emirates
Sponsor information
Hospital/treatment centre
Al Maryah Island
Abu Dhabi
Abu Dhabi
United Arab Emirates
| Phone | + 971 (2) 501 9000 |
|---|---|
| REC@clevelandclinicabudhabi.ae | |
| Website | https://www.clevelandclinicabudhabi.ae/en/pages/default.aspx |
Funders
Funder type
Other
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Roche Diagnostics Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. No additional documents are available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. A deidentified dataset will be stored on a password-protected work computer in keeping with REC regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/08/2021 | 22/08/2022 | Yes | No |
Editorial Notes
22/08/2022: Publication reference added.
17/02/2021: Trial's existence confirmed by Cleveland Clinic Abu Dhabi Research Ethics Committee.
