NCT05421468

Timing of Thyroxine Dose In Ramadan

Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-08-30
• Completion: 2022-10-30
• First posted: 2022-06-16
• Last updated: 2022-06-16

Locations

2 sites across 1 country: Saudi Arabia