Glutamine supplementation for cystic fibrosis

ISRCTN	ISRCTN22534872
DOI	https://doi.org/10.1186/ISRCTN22534872
Clinical Trials Information System (CTIS)	2007-006204-37
Protocol serial number	2007 version 3
Sponsor	University of Nottingham (UK)
Funder	Cystic Fibrosis Foundation (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andrew Fogarty
Scientific

Division of Epidemiology and Public Health
Clinical Science Building
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Phone	+44 115 823 1713
Email	andrew.fogarty@nottingham.ac.uk

Primary study design	Interventional
Study design	Parallel group placebo controlled randomised trial
Secondary study design	Randomised controlled trial
Scientific title	Glutamine supplementation for cystic fibrosis
Study objectives	Will glutamine supplementation for eight weeks improve sputum and blood inflammatory markers of cystic fibrosis activity?
Ethics approval(s)	Ethics approval received from the Nottingham Research Ethics Committee 2, 09/07/2008, ref: 08/H0408/26 Amendment approved 28/07/2008.
Health condition(s) or problem(s) studied	Cystic fibrosis
Intervention	1. Glutamine 21 g/day 2. Placebo Treatment will continue for eight weeks for both. Follow up will occur for this entire period and a telephone call will be made 4 weeks later.
Intervention type	Supplement
Primary outcome measure(s)	Change in inflammatory markers in induced sputum, measured at baseline and after eight weeks.
Key secondary outcome measure(s)	1. FEV1 2. Serum C-reactive protein (CRP) 3. Infectious load of Pseudomonas 4. Systemic blood neutrophil activity 5. Jensen clinical score All outcomes measured at baseline and after eight weeks.
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	44
Key inclusion criteria	1. Over 14 years old, male and female 2. Forced expiratory volume in one second (FEV1) greater than 40% predicted or receive regular nebulised saline treatment 3. Colonisation with Pseudomonas
Key exclusion criteria	1. Current pregnancy or breastfeeding 2. Recent pulmonary exacerbation in past month 3. Lung transplant 4. Recently diagnosed or uncontrolled diabetes 5. Cirrhosis or severe liver failure 6. Initiation of new pulmonary therapies in the past month
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2009

Division of Epidemiology and Public Health

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No

05/06/2017: Publication reference added.