Timing of Thyroxine Dose In Ramadan
Study Details
Study Description
Brief Summary
A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.
A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pre-Iftar (Breaking the fast) To take thyroxine at breaking of fast with sip of water then wait 30-60 miuntes to eat iftar (breakfast). |
Other: L-Thyroxine time B (5-15 minutes Before dawn)
Taking thyroxine at two different time points in relation to fasting and food intake; just before dawn and start of fast compared to the usual timing of 30-60minutes after the sunset breakfast meal.
|
| Experimental: Pre-Fajr (Starting the fast) To take thyroxine immediately before start of fast at predawn time regardless of last meal time. |
Other: L-Thyroxine time B (5-15 minutes Before dawn)
Taking thyroxine at two different time points in relation to fasting and food intake; just before dawn and start of fast compared to the usual timing of 30-60minutes after the sunset breakfast meal.
|
Outcome Measures
Primary Outcome Measures
- Thyroid function [6 - 8 weeks]
Change in TSH level
Eligibility Criteria
Criteria
Inclusion Criteria:
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Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
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Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.
Exclusion Criteria:
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Pregnant or lactating women.
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Uncontrolled thyroid function test three months prior Ramadan.
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Thyroid cancer patients who require suppressed TSH.
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Central Hypothyroidism, patient with acute illness.
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Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries
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Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
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Renal or hepatic disease:
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Creatinine clearance <0.6 ml/s or serum creatinine ≥200 μmol/l
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Alanine transferase ≥2.5 times the upper limit of normal
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Active liver disease including jaundice, chronic hepatitis, previous liver transplant
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Unwillingness to be randomized or to sign informed consent
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Known Psychiatric Disorders
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Known uncontrolled substance abuse or alcoholism
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reem Alamoudi | Jeddah | Saudi Arabia | 21423 | |
| 2 | KingAbullahIMRC | Jeddah | Saudi Arabia |
Sponsors and Collaborators
- King Abdullah International Medical Research Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICT22J-001-01