PULSES.
Trial name or title | Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia ‐ the pulses study |
Methods | Open‐label RCT. Parallel design. Location: Bristol, UK. Duration: 6 weeks. |
Participants | 122 participants. Age: 18 ‐ 64 years. Gender: females and males both eligible. Diagnosis: classical CAH due to 21‐hydroxylase deficiency. |
Interventions |
Arm 1: HC + placebo infusion. Arm 2: oral placebo + HC infusion. |
Outcomes |
Primary: ACTH in all participants and 17 OHP in people with CAH using subcutaneous pulsatile HC replacement. Secondary: cognitive, EMA, metabolic profile. |
Starting date | November 2014. |
Contact information | Dr Georgina Russell. |
Notes |