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Randomised controlled trial to evaluate tolerance of a new high energy product with vitamins, minerals and protein in subjects in need of high caloric oral nutritional support.


- candidate number9592
- NTR NumberNTR2923
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2011
- Secondary IDsCal.1.C/A  Danone Research C Centre for Specialised Nutrition
- Public TitleRandomised controlled trial to evaluate tolerance of a new high energy product with vitamins, minerals and protein in subjects in need of high caloric oral nutritional support.
- Scientific TitleRandomised controlled trial to evaluate tolerance of a new high energy product with vitamins, minerals and protein in subjects in need of high caloric oral nutritional support.
- ACRONYMCALEX
- hypothesisTolerance to new high energy product with vitamins, minerals and protein is equal to standard high energy product.
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. Subjects (male/female) ≥ 18 years of age at the start of the Baseline period;
2. Subject is prescribed high caloric oral nutritional support (subject can be current or new user);
3. In case of new users: MUST (Malnutrition Universal Screening Tool) score 1 (medium risk of malnutrition), or 2 or more (high risk of malnutrition);
4. Subject is expected to require high caloric oral nutritional support for at least 4 weeks;
5. Subject has given written informed consent;
6. Subject is able to comply with the protocol (e.g. answer questions).
- Exclusion criteria1. Known inflammatory bowel disease (e.g. Crohn's disease);
2. Pancreatitis or illness with known fat malabsorption;
3. Exposure to chemotherapy concomitantly or within two weeks prior to entry into the study;
4. Life expectancy of ≤ 3 months;
5. Known major hepatic dysfunction: symptomatic hepatic dysfunction or previous serum transaminase (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal;
6. Known major renal dysfunction: symptomatic renal dysfunction, previous serum creatinine level more than 1.8 times upper limit of normal, or requiring dialysis;
7. Ileostomy or colostomy;
8. Known galactosaemia;
9. Know cow's milk allergy;
10. Parenteral feeding;
11. Tube feeding;
12. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
13. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-mei-2012
- Target number of participants50
- InterventionsDuration of intervention: 28 days.
1. Intervention group: New high energy product with vitamins, minerals and protein;
2. Control group: Standard high energy product.
- Primary outcomeTolerance:
1. Daily stool frequency and consistency;
2. Occurrence and intensity of gastrointestinal symptoms.
- Secondary outcomeProduct appreciation: Product appreciation questionnaire.
- TimepointsScreening, Baseline, week 1, week 2, week 3, week 4, Follow Up.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. Marjolein Vossers
- CONTACT for SCIENTIFIC QUERIESPhD. Edward Sliwinski
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn this trial a new high energy product with vitamins, minerals and protein will be compared with standard high energy product on tolerance in subjects in need of high caloric oral nutritional support.
- Main changes (audit trail)
- RECORD31-mei-2011 - 11-aug-2012


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