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| Does oral creatine supplementation enhance recovery from a worsening of chronic bronchitis? |
| Source of record | UK Trials |
| ISRCTN | ISRCTN22287730 |
| Date ISRCTN assigned | 19/03/2008 |
| Local reference number(s) | RN06NT003 |
| Public title | Does oral creatine supplementation enhance recovery from a worsening of chronic bronchitis? |
| Scientific title | Does oral creatine supplementation enhance recovery from chronic obstructive pulmonary disease (COPD) exacerbation? |
| Acronym | N/A |
| Disease/condition/study domain | Chronic obstructive pulmonary disease (COPD) |
| 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. |
| Design/methodology | Randomised, stratified, double-blind, placebo controlled study |
| Research ethics review | Ethics approval received from the Glasgow East LREC on the 24th August 2006 (ref: 06/50704/45) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Chronic obstructive pulmonary disease (COPD) 2. Acute exacerbation COPD |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 29/05/2007 |
| Anticipated end date | 29/05/2008 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | 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). |
| Primary outcome measure(s) | Change in fat free mass. All endpoints measured at baseline and after treatment (2/52; or 42 doses). |
| Secondary outcome measure(s) | 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). |
| Sources of funding | 1. Chief Scientist Office (UK) (ref: CZG/2/261) 2. Glasgow Royal Infirmary (UK) - Endowment Fund (ref: 06Ref004 CH02 - Mullan) |
| Sponsor name | University of Glasgow (UK) |
| Sponsor details | Research and Enterprise University Avenue Glasgow United Kingdom G12 8QQ |
| Sponsor website | http://www.gla.ac.uk/ |
| Contact name | Prof Michael Lean |
| Contact details | Dept. of Human Nutrition University of Glasgow Glasgow Royal Infirmary Glasgow United Kingdom G31 2ER |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22287730 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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