Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2007
Date assigned
21/12/2007
Last edited
04/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Fogarty

ORCID ID

Contact details

Division of Epidemiology and Public Health
Clinical Science Building
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 823 1713
andrew.fogarty@nottingham.ac.uk

Additional identifiers

EudraCT number

2007-006204-37

ClinicalTrials.gov number

Protocol/serial number

2007 version 3

Study information

Scientific title

Acronym

Study hypothesis

Will glutamine supplementation for eight weeks improve sputum and blood inflammatory markers of cystic fibrosis activity?

Ethics approval

Ethics approval received from the Nottingham Research Ethics Committee 2 on the 9th July 2008 (ref: 08/H0408/26). Amendment approved on the 28th July 2008.

Study design

Parallel group, placebo controlled, randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Glutamine supplementation

Primary outcome measures

Change in inflammatory markers in induced sputum, measured at baseline and after eight weeks.

Secondary outcome measures

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.

Overall trial start date

01/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

44

Participant 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

Recruitment start date

01/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Epidemiology and Public Health
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG5 1PB
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk

Funders

Funder type

Research organisation

Funder name

Cystic Fibrosis Foundation (USA)

Alternative name(s)

CF Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes