Does oral creatine supplementation enhance recovery from a worsening of chronic bronchitis?

ISRCTN	ISRCTN22287730
DOI	https://doi.org/10.1186/ISRCTN22287730
Secondary identifying numbers	RN06NT003

Submission date: 03/08/2007
Registration date: 19/03/2008
Last edited: 08/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Lean
Scientific

Dept. of Human Nutrition
University of Glasgow
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom

Study information

Study design	Randomised stratified double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Does oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation?
Study objectives	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(s)	Glasgow East LREC, 24/08/2006, ref: 06/50704/45
Health condition(s) or problem(s) studied	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
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 study start date	29/05/2007
Completion date	29/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	1. Chronic obstructive pulmonary disease (COPD) 2. Acute exacerbation COPD
Key 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
Date of first enrolment	29/05/2007
Date of final enrolment	29/05/2008

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Glasgow

Glasgow
G31 2ER
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

Research and Enterprise
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Government

Chief Scientist Office (UK) (ref: CZG/2/261)
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Thesis results	results	07/01/2013		No	No

Editorial Notes

08/06/2017: Publication reference added.