Comparing Two-time Points of Thyroid Hormone Replacement... | NCT03988517

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

NCT03988517

Sponsor

Hamad Medical Corporation

Status

Completed

Last Update Posted

Jun 19, 2019Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

Hypothyroidism

Interventions

timing of receiving the drug

Countries

Qatar

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Jan 8, 2018Actual

Completion Date

Jan 8, 2018Actual

First Submitted Date

Jun 11, 2019

First Submission Date that Met QC Criteria

Jun 14, 2019

First Posted Date

Jun 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2019

Last Update Posted Date

Jun 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. ZEINAB DABBOUS, Consultant Endocrine, Hamad Medical CorporationPrincipal Investigator

Lead Sponsor

Hamad Medical CorporationINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Hypothyroidism requires regular replacement with levothyroxine to achieve euthyroidism (thyroid hormone status within the normal range). Usually, levothyroxine is taken orally in the morning on a daily basis. In clinical practice, the investigators have observed that this levothyroxine replacement is sub-optimal resulting in higher levels of thyroid stimulating hormone. Based on this observation, the investigators conducted this study to examine whether timing of oral intake of levothyroxine during the holy month of Ramadan will affect achievement of euthyroidism. They recruited 96 hypothyroid patients taking levothyroxine, attending Hamad endocrine outpatient clinics, who were fasting during Ramadan( May-June 2017)and for whom there is no clinical contraindication to fasting. Patients were randomly assigned to two time points for taking levothyroxine:

A. 30 minutes before the Iftar meal B. 30 minutes before Suhour The primary outcome was the change in thyroid stimulating hormone (TSH) before and after Ramadan. The null hypothesis is that there is no difference in TSH between the two groups.

The findings from the study will help in the clinical care of patients with hypothyroidism in Ramadan. Hypothyroidism is common worldwide and many Muslims will require the appropriate advice regarding management of hypothyroidism in Ramadan.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
timing of receiving the drug	Other	each group took levothyroxine in different timing	Levothyroxine at Suhour levothyroxine at Iftar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in TSH level	To evaluate the change in TSH level before and after Ramadan in the two groups.	1 month

Secondary Outcomes

Measure	Description	Time Frame
convenience and compliance	To determine in each group if the timing of levothyroxine dose was convenient and check the compliance with instructions to take levothyroxine in the assigned time. Done through clinical interview	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wajiha Abu Haliqa, MD	Hamad Medical Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamad General Hospital		Doha		3050	Qatar

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share individual participant data, but can provide them for researchers who ask for it

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007037	Hypothyroidism
D005215	Fasting

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided