| 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
|
|
|
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
|
|
|
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 . |