Condition category
Respiratory
Date applied
03/08/2007
Date assigned
19/03/2008
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively 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

Prof Michael Lean

ORCID ID

Contact details

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

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 below 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 measures

Change in fat free mass.

All endpoints 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

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

http://www.gla.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes