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| [ ...Back to search results ] | [ Print-friendly version ] |
| A pilot trial of energy-dense supplements in malnourished patients |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN96923961 |
| Date ISRCTN assigned | 22/06/2007 |
| Local reference number(s) | NCC100 |
| Public title | A pilot trial of energy-dense supplements in malnourished patients |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Malnutrition in the elderly |
| Study hypothesis | Investigate the role of energy-dense supplements in the management of patients with malnutrition. |
| Design/methodology | Prospective, interventional, randomised, parallel, three-arm study |
| Research ethics review | Approval received from the Bath Local Research Ethics Committee on the 22nd March 2007 (ref: 07/Q2001/46). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male or female 2. Aged greater than 50 years 3. At risk of malnutrition 4. Competent to provide written informed consent and able to answer questions 5. No requirement for tube or parenteral feeding 6. Willingness to take part in the trial and to follow the trial protocol |
| Participants - exclusion criteria | 1. Requirement for tube or parenteral nutrition 2. Patients receiving palliative care 3. Patients with chronic renal disease requiring dialysis 4. Patients with liver failure 5. Participation in other studies 6. Taking a supplement in the last four weeks |
| Patient information material | |
| Anticipated start date | 04/06/2007 |
| Anticipated end date | 30/12/2007 |
| Status of trial | Completed |
| Target number of participants | 75 |
| Interventions | The interventions are: 1. Standard dietary care 2. A high-energy supplement 3. A high energy supplement plus micronutrients Duration: four weeks Dosage: 400 kcal/day Follow-up: patients are taking part in the trial for four weeks only. There is no further follow up. |
| Primary outcome measure(s) | Nutrient intake, assessed by diet diary at weeks one, two and four. |
| Secondary outcome measure(s) | 1. Gastro-Intestinal (GI) tolerance, using Bristol Stool Chart at weeks one, two and four 2. Product compliance, by daily questionnaire throughout the four weeks and product acceptability by questionnaire in weeks two and four 3. Appetite, measured in weeks one and four by questionnaire 4. Anthropometry (weight and Body Mass Index [BMI]), measured in weeks one, two and four 5. Muscle function, measured by hand grip dynamometry in weeks one and four 6. Quality of Life, measured using EuroQol EQ-5D questionnaire in weeks one and four 7. Blood lipids and micronutrients, measured in in weeks one and four 8. Safety, falls assessment measured using Berg Balance Scale at weeks one and four |
| Sources of funding | Nutricia Clinical Care (UK) |
| Sponsor name | Nutricia Clinical Care (UK) |
| Sponsor details | White Horse Business Park Trowbridge Wiltshire United Kingdom BA14 0XQ |
| Sponsor website | http://www.nutricia-clinical-care.co.uk/asp/show_subject.asp |
| Contact name | Dr Lucio Fumi |
| Contact details | Nutricia Clinical Care Whitehorse Business Park Trowbridge Wiltshire United Kingdom BA14 0XQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96923961 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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