Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RN06NT003
Study information
Scientific title
Does oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation?
Acronym
Study hypothesis
In patients with chronic obstructive pulmonary disease (COPD) exacerbation, supplementation with 5 g of creatine monohydrate three times daily prevents loss of, or increases, fat free mass after 14 days of treatment when compared to placebo.
Ethics approval
Glasgow East LREC, 24/08/2006, ref: 06/50704/45
Study design
Randomised stratified double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
The study will have two arms:
1. Standard care with placebo:
This will comprise best clinical practice defined by National Institute for Clinical Excellence (NICE) (Clinical Guideline 12: "Management of chronic obstructive pulmonary disease in adults in primary and secondary care." February 2004). Placebo consists of 5 g lactose mixed with 30 g glucose monohydrate, given mixed with hot water as a drink, three times a day.
2. Standard care with creatine:
This will comprise best clinical practice defined by NICE (Clinical Guideline 12: "Management of chronic obstructive pulmonary disease in adults in primary and secondary care." February 2004). Creatine supplementation is given as 5 g of creatine monohydrate mixed with 30 g glucose monohydrate, given mixed with hot water as a drink, three times a day. There is evidence that concomitant administration of glucose increases muscle uptake of creatine.
Patients will receive the investigational supplement for 14 days (42 doses).
Details of investigational supplement:
Creatine is naturally found in the body and is present in the diet in fish and meat (herring contains 6.5 - 10 g creatine per kg). Approximately 50% of total body creatine is provided by the diet with the rest produced endogenously from the amino acids arginine, glycine and methionine in the liver and kidneys. The majority of body creatine is stored in skeletal muscle, where the creatine transporter protein moves creatine across the plasma membrane from the blood against a large concentration gradient. Creatine spontaneously degrades to creatinine, which is excreted by the kidneys. Creatine is rapidly phosphorylated to phosphocreatine which provides essential energy to exercising muscle via re-phosphorylation of adenosine diphosphate (ADP) to adenosine triphosphate (ATP).
Intervention type
Supplement
Phase
Not Specified
Drug names
Creatine supplementation
Primary outcome measure
Fat free mass, measured at baseline and after treatment (2/52; or 42 doses)
Secondary outcome measures
1. Anthropometry
2. Hand-grip and strength
3. Maximal expiratory pressure (MEP)/maximal inspiratory pressure (MIP)/sniff nasal inspiratory pressure (SNIP)
4. Rise to go test
5. Six minute walk test (SMWT)
6. High sensitivity C-reactive protein (hsCRP)
7. Interleukin-six (IL-6)
8. Tumour necrosis factor-alpha (TNF-α)
9. Digit span
10. Medical Research Council (MRC) dyspnoea scale
11. Hospital Anxiety and Depression (HAD) score
12. London Chest Activity of Daily Living (LCADL) score
13. Baseline/Transition Dyspnoea Index (BDI/TDI)
All endpoints measured at baseline and after treatment (2/52; or 42 doses)
Overall trial start date
29/05/2007
Overall trial end date
29/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic obstructive pulmonary disease (COPD)
2. Acute exacerbation COPD
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Alternative diagnosis for acute presentation
2. Active cardiac, neurological, neoplastic disease
3. Diabetes
4. Significant locomotor disease
5. Renal or hepatic impairment
6. Persisting decompensated respiratory acidosis
7. Depressed cognitive function
8. Terminal condition
9. Pregnant, lactating, or wish to become pregnant
10. Implanted cardiac pacemaker resynchronise or defibrillator device
11. Enteral route contraindicated
Recruitment start date
29/05/2007
Recruitment end date
29/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Glasgow
Glasgow
G31 2ER
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
Research and Enterprise
University Avenue
Glasgow
G12 8QQ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (UK) (ref: CZG/2/261)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Funder name
Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2013 results in: http://theses.gla.ac.uk/id/eprint/3635