| Source of record | UK Trials |
| ISRCTN | ISRCTN22534872 |
| Date ISRCTN assigned | 21/12/2007 |
| Local reference number(s) | 2007 version 3 |
| Public title | Glutamine supplementation for cystic fibrosis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cystic fibrosis |
| Study hypothesis | Will glutamine supplementation for eight weeks improve sputum and blood inflammatory markers of cystic fibrosis activity? |
| Design/methodology | Parallel group, placebo controlled, randomised trial |
| Research ethics review | Ethics approval pending as of 22/11/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 44 |
| Interventions | 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. |
| Primary outcome measure(s) | Change in inflammatory markers in induced sputum, measured at baseline and after eight weeks. |
| 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. |
| Sources of funding | Cystic Fibrosis Foundation (USA) |
| Sponsor name | University of Nottingham (UK) |
| Sponsor details | University Park
Nottingham
United Kingdom
NG5 1PB |
| Sponsor website | http://www.nottingham.ac.uk |
| Contact name | Dr Andrew Fogarty |
| Contact details | Division of Epidemiology and Public Health
Clinical Science Building
Nottingham City Hospital
Nottingham
United Kingdom
NG5 1PB |
| Contact telephone | +44 (0)115 823 1713 |
| Contact email | andrew.fogarty@nottingham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22534872 |
| Date last extracted from ISRCTN register | 17/04/2008 |
