Timing of Thyroxine Dose In Ramadan

Hypothyroidism Clinical Trial

Official title:

Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421468
• Other study ID #: ICT22J-001-01
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: June 2022
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.

• Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.

Exclusion Criteria:

• Pregnant or lactating women.

• Uncontrolled thyroid function test three months prior Ramadan.

• Thyroid cancer patients who require suppressed TSH.

• Central Hypothyroidism, patient with acute illness.

• Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries

• Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications

• Renal or hepatic disease:

• Creatinine clearance <0.6 ml/s or serum creatinine =200 µmol/l

• Alanine transferase =2.5 times the upper limit of normal

• Active liver disease including jaundice, chronic hepatitis, previous liver transplant

• Unwillingness to be randomized or to sign informed consent

• Known Psychiatric Disorders

• Known uncontrolled substance abuse or alcoholism

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	KingAbullahIMRC	Jeddah
Saudi Arabia	Reem Alamoudi	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid function	Change in TSH level	6 - 8 weeks