Randomised controlled trial of the benefits of oral essential amino acids in haemodialysis patients at high risk for hospitalisation

ISRCTN	ISRCTN21593740
DOI	https://doi.org/10.1186/ISRCTN21593740
Secondary identifying numbers	CT 00-AMI-003

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Joseph Eustace
Scientific

Department of Nephrology
Cork University Hospital
Cork
-
Ireland

Study design	Randomised, multicentre, double-blind, parallel, placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Can health parameters be improved in patients on maintenance haemodialysis by oral supplementation with essential amino acids?
Ethics approval(s)	Western Institutional Review Board (USA) approved on 27 November 2002 (Study number: 1033247, Invest. number: 67275).
Health condition(s) or problem(s) studied	End Stage Renal Disease (ESRD), and haemodialysis
Intervention	Essential amino acid supplementation/placebo treatment in haemodialysis patient for six months or until a primary end-point is reached.
Intervention type	Supplement
Primary outcome measure	The primary outcome was comparing the time of the composite primary outcome of : 1. Hospitalisation, other than for uncomplicated dialysis access procedure 2. Prolonged Emergency Room (ER) visit (more than 16 hours) 3. Out of hospital death
Secondary outcome measures	Secondary efficacy analyses, for the following outcomes comparing the change in the given parameter from baseline to the last available study measurement: 1. Change in subjective global assessment 2. Change in grip strength 3. Change in quality of life measures (using Short Form 12 instrument) 4. Change in lowest post dialysis weight
Overall study start date	09/01/2003
Completion date	20/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Patients planned for approximately 400. Patients obtained 84
Key inclusion criteria	1. Patients on maintenance haemodialysis for at least four months at high risk of hospitalisation. This is defined as: a. no more than two weeks post discharge from an acute hospitalisation and a serum albumin below 4.0 g/dl b. a serum albumin below 3.8 g/dl
Key exclusion criteria	1. Patients who have difficulties in taking pills, due to problems swallowing or intractable vomiting 2. Patients who have a short time life expectancy or are awaiting non-cadaveric kidney transplantation
Date of first enrolment	09/01/2003
Date of final enrolment	20/01/2006

Department of Nephrology

Cork
-
Ireland

Recip AB (Sweden)
Industry

Lagervägen 7
Haninge
SE -136 50
Sweden

Website	http:// www.recip.se
"ROR"	https://ror.org/01apnjb23

Government

National Institute of Diabetes and Digestive and Kidney diseases (NIDDK), National Institutes of Health (USA)

No information available

Recip AB (Sweden)

No information available

Gambro Corporate Research

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan