| CTRI Number |
CTRI/2019/06/019896 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Medical problems in children with congenital adrenal hyperplasia |
|
Scientific Title of Study
|
Cross sectional evaluation of growth, metabolic, and psychosocial issues of children with congenital adrenal hyperplasia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashima Dabas |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
01123236031 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aashima Dabas |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
01123236031 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashima Dabas |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
01123236031 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital and GIPMER |
| Address |
Bahadur Shah Zafar Marg, New Delhi |
| 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 |
| AASHIMA DABAS |
Maulana Azad Medical College and Lok Nayak Hospital |
Department of Pediatrics, OPD and ward 14, Lok Nayak Hospital, JLN Marg, New Delhi
Central
DELHI |
9968604424
dr.aashimagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E250||Congenital adrenogenital disordersassociated with enzyme deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
28.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of congenital adrenal hyperplasia detected with clinical features of CAH with elevated serum 17-hydroxy progesterone levels |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of growth abnormalities, metabolic syndrome, pubertal abnormalities
|
Single |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between growth with cumulative steroid doses
Association between growth and serum 17OHP levels
Quality of life
|
single |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Congenital adrenal hyperplasia (CAH) is a common disorder (incidence 1:10,000 births) which presents as virilization in girls to life threatening adrenal crisis to milder non-classical forms later in life. To dismay, affected girls with CAH often face social stigma and abandonment to be later adopted by Hijra community. Affected infants may remain unrecognized and may succumb to adrenal crisis in mild infection. Delayed identification may compromise on the height outcomes, metabolic well being and quality of life of patients with CAH. Currently there is lack of data on the follow up outcomes of CAH patients. Hence a screening and monitoring framework is desirable for CAH subjects. Currently there is limited literature available on profile of medical and psychosocial morbidities as retrospective studies have evaluated only on handful of CAH patients. Thus, the current study will highlight the medical and psychosocial issues in patients with CAH for improved case management and health outcomes. |