Timing of Thyroxine Dose In Ramadan

Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial

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

Study Overview

• Status: Recruiting
• Conditions: Hypothyroidism
• Intervention / Treatment: Other: L-Thyroxine time B (5-15 minutes Before dawn)

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21423
    • Recruiting
    • Reem Alamoudi
    • Contact: Reem Alamoudi; Phone Number: 0122266666; Email: amoudir@ngha.med.sa
    • Sub-Investigator: Samah Nawar, MD
    • Sub-Investigator: Hiba Alharbi, MD
    • Sub-Investigator: Abdullah Alzahrani, MD
    • Principal Investigator: Ali Alqarni, MD
    • Principal Investigator: Yousef Saleh, MD
    • Sub-Investigator: Anwar Borai
    • Sub-Investigator: Majed Ramadan, PhD
  • Jeddah, Saudi Arabia
    • Recruiting
    • KingAbullahIMRC
    • Contact: Reem M Alamoudi; Phone Number: 966505641595; Email: amoudir@ngha.med.sa, refal2001@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid function	Change in TSH level	6 - 8 weeks

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2022
• Primary Completion (ANTICIPATED): August 30, 2022
• Study Completion (ANTICIPATED): October 30, 2022

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (ACTUAL): June 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: ICT22J-001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No