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Effects of Steroid Therapy on Quality of Life and Adverse Health outcomes in Primary Adrenal Insufficiency

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072253
Enrollment
60
Registered
2024-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E271- Primary adrenocortical insufficiency

Interventions

Intervention1: 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 adr

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1.Any secondary cause of adrenal insufficiency. 2. Pregnancy. 3.Chronic disease like CKD, CLD and chronic infections

Design outcomes

Primary

MeasureTime frame
Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiencyTimepoint: outcome will be assessed at baseline, 24 weeks & 48 weeks.—

Secondary

MeasureTime frame
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.Timepoint: one year—

Countries

India

Contacts

Public ContactVenugopalan G

Jawaharlal Institute of Postgraduate Medical Education and Research

sadishkk@gmail.com9629528518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026