A Low dose versus conventional dose of steroids as replacement dose in adrenal insufficiency patients

A study of 3.75 CG prednisolone versus hydrocortisone, conventional dose of prednisolone as replacement dose in adrenal insufficiency patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045868

Enrollment

Registered

2022-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: E274- Other and unspecified adrenocortical insufficiency

Interventions

Intervention1: low dose of steroids versus conventional dose in patients with adrenal insufficiency: Participants will either be on baseline therapy of prednisolone 5mg or more, or standard regimen hy

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed with adrenal insufficiency (AI) for over 6 months according to standard diagnostic criteria 2. Established on stable HC or prednisolone 5mg or more replacement, dose not altered for at least 4 months 3.Individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months; 4. Individuals who are able and willing to give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Individuals who are unable to give informed consent 2. Pregnancy (determined by patients self-reporting pregnancy status) 3. Patients using the combined oral contraceptive pill

Design outcomes

Primary

Measure	Time frame
At the start and after 4 months on the alternate medication, we will establish the effects of the medication on: 1. Bone health: by measurement of bone turnover markers if available: procollagen type-1 N- terminal propeptide (P1NP), Parathyroid hormone, bone profiles, Vitamin D and urinary N-terminal telopeptide (NTX).Timepoint: first visit , 3 months , 1 year from the first time point	—

Secondary

Measure	Time frame
1. Cardiovascular risk: by recording observations such as heart rate, blood pressure and waist-hip circumference ratios. We will also measure biochemical indicators of cardiovascular risk by measuring lipid profiles, high-sensitivity CRP. 2. Glycaemia: as assessed by measuring glucose and HbA1c. 3. Safety: as assessed by reporting of symptoms of steroid deficiency or excess and myopathy. We will also perform routine safety bloods (including full blood count, renal profile, and liver function tests) 4. Efficacy of replacement and wellbeing as assessed by a customised subjective health questionnaire.Timepoint: first visit , 3 months , 1 year from the first time point	—

Measure

Time frame

1. Cardiovascular risk: by recording observations such as heart rate, blood pressure and waist-hip circumference ratios. We will also measure biochemical indicators of cardiovascular risk by measuring lipid profiles, high-sensitivity CRP. 2. Glycaemia: as assessed by measuring glucose and HbA1c. 3. Safety: as assessed by reporting of symptoms of steroid deficiency or excess and myopathy. We will also perform routine safety bloods (including full blood count, renal profile, and liver function tests) 4. Efficacy of replacement and wellbeing as assessed by a customised subjective health questionnaire.Timepoint: first visit , 3 months , 1 year from the first time point

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Countries

India

Contacts

Public ContactPriyadarshini Rajakumar

Sri Ramachandra medical college and research institute

mshriraam@gmail.com9003047709

Outcome results

None listed

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