| CTRI Number |
CTRI/2024/07/071017 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Autonomic dysfunction in children and adolescents treated for hypothyroidism. |
|
Scientific Title of Study
|
AUTONOMIC DYSFUNCTION IN CHILDREN AND ADOLESCENTS TREATED FOR 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 Rahul Choudhary |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 15, Department of paediatrics, Lok Nayak Hospital and Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
7014480667 |
| Fax |
|
| Email |
rchoudhary90001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9868479647 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashima Dabas |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9868479647 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, 110002, India |
| 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 Rahul Choudhary |
Lok Nayak Hospital |
ANS Lab, 1st floor, Department of physiology and Ward 15, Department of Paediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
7014480667
rchoudhary90001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals (Lok Nayak, G. B Pant Institute of Post Graduate Medical Education (GIPMER) and Research Hospital, Guru Nanak Eye Centre, New Delhi - 110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E031||Congenital hypothyroidism withoutgoiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Case: Children of age group 8- 18 years with primary hypothyroidism maintaining euthyroid status on L-thyroxine therapy for at least 6 months.
Controls: Age and gender matched apparently healthy children who are euthyroid of age group 8-18 years. |
|
| ExclusionCriteria |
| Details |
1. Undergoing structured physical activity regime over last 3 months.
2. Fever or systemic illness requiring hospitalization in preceding 4 weeks.
3. Previously diagnosed hypertension, renal disease or cardiovascular disease.
4. Any other associated endocrinal disorder like diabetes, adrenal disorders.
5. On any drug which might affect heart rate like beta blockers/ agonists/ calcium channel blockers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean difference in heart rate variability of cases and controls.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean difference in beat-to-beat variability in cases and controls.
Association of sleep/wake cycle with Continuous Ambulatory Blood Pressure Monitoring in cases.
Proportion of cases with abnormal Continuous Ambulatory Blood Pressure records.
Correlation of Heart Rate Variability, mean Systolic Blood Pressure and Diastolic Blood Pressure with fT3, fT4 and TSH levels and disease duration. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The autonomic nervous system controls the heart through complex interactions between sympathetic and parasympathetic divisions, producing fluctuations in heartbeat intervals. The greater the fluctuations in the beat-to-beat interval, the better the cardiovascular system functions to adapt and respond to internal and external stimuli.
Heart rate variability analysis is a sensitive measure of autonomic dysfunctions manifested as sympathovagal imbalance in humans. It is a non-invasive, widely applied method for cardiac autonomic assessment, and has been proposed as a marker for cardiovascular disease.
Earlier studies in adults have shown the autonomic dysfunction such as difference in HRV and heart rate in newly diagnosed patients with hypothyroidism as compared to controls. A few studies have compared pre-treatment vs post treatment dysautonomia in hypothyroidism to document partial improvement in ANS on treatment with levo-thyroxine.
It is postulated that this dysautonomia will normalize on continued therapy with levothyroxine. At present, satisfactory control of disease is considered when euthyroidism is achieved in the absence of any clinical features of hypothyroidism or hyperthyroidism. However, there are no studies that have evaluated status of ANS function in children treated for hypothyroidism. |