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CTRI Number  CTRI/2024/04/065960 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Daily Versus Weekly Levothyroxine in Hypothyroidism patients 
Scientific Title of Study   A Randomized Control Trial of Efficacy and Safety of Daily Versus Weekly Levothyroxine T4 in Hypothyroidism 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surjit Singh 
Designation  Professor 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur 
Address  Department of Pharmacology, All India Institute of Medical Sciences Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7973231984  
Fax    
Email  sehmby_ss@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanchi Sukhija 
Designation  Senior Resident 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur 
Address  Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9552257731  
Fax    
Email  sanchisukh7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanchi Sukhija 
Designation  Senior Resident 
Affiliation  Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur 
Address  Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9552257731  
Fax    
Email  sanchisukh7@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur, Rajasthan 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  AIIMS, Basni, Jodhpur - 342005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surjit Singh  AIIMS, Jodhpur  Room 147, Block 1C, Dept. of Endocrinology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN 
7973231984

sehmby_ss@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Jodhpur Institutional Ethics Committee (Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Levothyroxine  Levothyroxine will be given once daily for 12 weeks. 
Intervention  Levothyroxine   Levothyroxine will be given once weekly for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Known case of Primary Hypothyroidism
2.Patients willing to give written informed consent 
 
ExclusionCriteria 
Details  1.Pregnancy and lactating women
2.Patients requiring Levothyroxine dose more than 150 mcg or less than 25 mcg
3.Critical care illness requiring hospitalization in ICU
4.Known cases of pituitary disorders
5.Women currently on Oral Contraceptives Pills or planning to take OCPs
6.Chronic Kidney disease patients with serum creatinine more than 1.8
7.Known cases of nephrotic syndrome
8.All patients diagnosed with Rheumatoid Arthritis
9.Patients with TSH more than 20 milli international unit per liter 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To compare the change in thyroid hormone (T3, T4, TSH) levels between two groups  Baseline and 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the mean change in Quality-of-Life scores (SF-36 scaling tool) from baseline to 12 weeks.  Baseline and 12 weeks  
To compare the laboratory parameters namely LDL, hsCRP, CBC, Urinary protein and NT-pro BNP in two study groups.  Baseline and 12 weeks  
To compare the adverse events between two treatment groups  Baseline and 12 weeks 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hypothyroidism is one of the most common endocrine disorders. It is found in about 6 % to 17 % of the normal population. It is more commonly seen in females and elderly. The severity of signs, symptoms and complications depends upon degree and time of untreated thyroid failure. Thyroxine also known as Levothyroxine (T4) is derived from thyroid gland itself. Although liothyronine (T3) is derived from T4 by deiodination. Various adverse effects has been noted in patients with hypothyroidism leading to poor Quality of life (QOL). Majority of the hypothyroid patients are seen with mood and cognitive symptoms. In the last few years, weekly T4 has been tested to replace daily T4 regimen because of non-compliance with the patients to weekly T4 regimen (5,6). The major reasons for non-compliance were fasting state before taking the medication early morning, not able to have other drugs or food products containing ferrous sulphate, calcium carbonates or bile acid sequestrants to prevent the interference with the absorption of levothyroxine. It was seen that non-compliance could also lead to metabolic disturbances as well. Because of all these factors affecting daily activities further leading to poor quality of life has led to the investigation of new therapeutic alternatives including weekly high dose of levothyroxine or intermittent T4 dosing further leading to better compliance in patients. Therefore, this study is planned to explore the efficacy and safety of weekly T4 dosing to daily T4 dosing by measuring the level of TSH and seeing the effect on quality of life using SF-36 scale scoring .

 
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