| CTRI Number |
CTRI/2024/08/072253 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Steroid Therapy on Quality of Life and Adverse Health outcomes in Primary Adrenal Insufficiency |
|
Scientific Title of Study
|
Comparison of effects of hydrocortisone and prednisolone re-placement therapy on quality of life, metabolic and bone health parameters in primary adrenal insufficiency -an open-label parallel arm randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh kumar |
| Designation |
SR PG endocrinology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 2 Department of endocrinology, 4th floor, SSB JIPMER, Dhanvantri nagar Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09461632552 |
| Fax |
|
| Email |
jr7971@jipmer.ac.nic |
|
Details of Contact Person
Scientific Query
|
| Name |
Sadishkumar Kamalanathan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
4th floor, Endocrinology department, SSBJIPMER Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9629528518 |
| Fax |
|
| Email |
sadishkk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venugopalan G |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Geriatric Medicine
JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9597849988 |
| Fax |
|
| Email |
drvenu88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 2 Department of endocrinology, 4th floor, SSB JIPMER, Dhanvantri Nagar Puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mukesh kumar |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Room no 2 Department of endocrinology, 4th floor, SSB
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY |
9461632552
jr7971@jipmer.ac.nic |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E271||Primary adrenocortical insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrocortisone and effect on quality of life, metabolic and bone health parameters in primary adrenal insufficiency |
quality of life, metabolic and bone health parameters in primary adrenal insufficiency in compare to prednisolone at 0,6,12 months |
| Comparator Agent |
Prednisolone and effect on quality of life, metabolic and bone health parameters in primary adrenal insufficiency |
Prednisolone and effect on quality of life, metabolic and bone health parameters in primary adrenal insufficiency in compare hydrocortisone at 0,6,12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of primary adrenal insufficiency including classical CAH of age 18 to 65 years being treated with stable dose of glucocorticoid for last 3 months. |
|
| ExclusionCriteria |
| Details |
1.Any secondary cause of adrenal insufficiency.
2. Pregnancy.
3.Chronic disease like CKD, CLD and chronic infections
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiency |
outcome will be assessed at baseline, 24 weeks & 48 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the change in cardiometabolic parame-ters (HOMA2IR, adiponectin, leptin, hs-CRP) and bone turnover markers (sclerostin, P1NP, CTX) in PAI patients on hydrocortisone or prednisolone treatment at baseline, 6 month and 1 year.
2.To compare the change in lumbar spine BMD and Trabecular bone score (TBS) over 1 year in PAI patients on hydrocortisone or prednisolone replacement therapy.
3.To compare the change in body composition parameters, include lean body mass, fat mass, fat per-centage and android to gynecoid ratio using bioimpedance analyzer (BIA) and dual energy x-ray absorptiometry (DXA) in patients on hydrocortisone or prednisolone at baseline,6month and 1 year. |
one year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/08/2024 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included mkchoudharyjmc@gmail.com).
- For how long will this data be available start date provided 05-09-2025 and end date provided 05-07-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
: Hydrocortisone and prednisolone are the preferred agents for treating primary adrenal insufficiency (PAI). Hydrocortisone is still the preferred agent used to treat PAI. However, endocrinologists lack consensus regarding the impact of different steroid regimens on quality of life, cardiometabolic outcome, and bone health. Despite this preference, some studies have suggested that prednisolone may be as effective as hydrocortisone in managing primary adrenal insufficiency with fewer adverse hypertension, weight gain, and decreased BMD. There is a lack of randomized controlled trials comparing the two medications in terms of their effects on cardiometabolic risk factors, body composition parameters, bone turnover markers, and quality of life. | Novelty: To the best of our knowledge, there is no prior literature from India studying the effect of hydrocortisone and prednisolone replacement therapy on quality of life, cardiometabolic and bone health in primary adrenal insufficiency |
|