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Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypothyroidism | Other: timing of receiving the drug | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 106 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan |
| Actual Study Start Date : | February 1, 2017 |
| Actual Primary Completion Date : | January 8, 2018 |
| Actual Study Completion Date : | January 8, 2018 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: levothyroxine at Iftar
Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)
|
Other: timing of receiving the drug
each group took levothyroxine in different timing
|
|
Active Comparator: Levothyroxine at Suhour
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 [ Time Frame: 1 month ]To evaluate the change in TSH level before and after Ramadan in the two groups.
- convenience and compliance [ Time Frame: 1 month ]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
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Primary hypothyroidism who had stable TSH over the last 6 months prior to the study period
- Age between 18-70 years old
- Patients who planned to fast during Ramadan.
Exclusion Criteria:
- Patients with any end organ damage
- Pregnant ladies
- Patients with thyroid cancer
- Patients not adhering to medications
- Patients who had a clinical contraindication to observe fasting.
| Qatar | |
| Hamad General Hospital | |
| Doha, Qatar, 3050 | |
| Principal Investigator: | Wajiha Abu Haliqa, MD | Hamad Medical Corporation |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 11, 2019 | ||||||
| First Posted Date ICMJE | June 17, 2019 | ||||||
| Last Update Posted Date | June 19, 2019 | ||||||
| Actual Study Start Date ICMJE | February 1, 2017 | ||||||
| Actual Primary Completion Date | January 8, 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Change in TSH level [ Time Frame: 1 month ] To evaluate the change in TSH level before and after Ramadan in the two groups.
|
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| Original Primary Outcome Measures ICMJE |
Difference in TSH level [ Time Frame: 1 month ] To evaluate the difference in TSH level between the two treatment groups.
|
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
convenience and compliance [ Time Frame: 1 month ] 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
|
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| Original Secondary Outcome Measures ICMJE |
convenience and compliance [ Time Frame: 1 month ] To determine the patient preference and compliance(by clinical interview).
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan | ||||||
| Official Title ICMJE | A Prospective Study Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description |
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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Hypothyroidism | ||||||
| Intervention ICMJE | Other: timing of receiving the drug
each group took levothyroxine in different timing
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
106 | ||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | January 8, 2018 | ||||||
| Actual Primary Completion Date | January 8, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Qatar | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03988517 | ||||||
| Other Study ID Numbers ICMJE | ZDABBOUS | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Dr. ZEINAB DABBOUS, Hamad Medical Corporation | ||||||
| Study Sponsor ICMJE | Hamad Medical Corporation | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Hamad Medical Corporation | ||||||
| Verification Date | June 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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