Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan

NCT03988517 | Completed

• 1 other identifier: ZDABBOUS
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

fasting

Outcome Measures

Primary Outcomes (1)

• Change in TSH level

  To evaluate the change in TSH level before and after Ramadan in the two groups.

  1 month

Secondary Outcomes (1)

• convenience and compliance

  1 month

Study Arms (2)

levothyroxine at Iftar

ACTIVE COMPARATOR

Patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar)

Other: timing of receiving the drug

Levothyroxine at Suhour

ACTIVE COMPARATOR

Patients took levothyroxine 30 minutes before an early morning meal before sunrise (suhour)

Other: timing of receiving the drug

Interventions

timing of receiving the drug OTHER

each group took levothyroxine in different timing

Levothyroxine at Suhour; levothyroxine at Iftar

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad General Hospital

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Hypothyroidism; Fasting

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Wajiha Abu Haliqa, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Endocrine

Model Details: patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: February 1, 2017
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)