DenutritionPhase 3NCT00560729
Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
A Phase 3 study testing Renutryl 500, Generique and Generique + Renutryl 500 in people with Denutrition, run by Société des Produits Nestlé (SPN) at 3 sites in France.
Trial summary
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Denutrition
- What is being tested?
- Renutryl 500, Generique and Generique + Renutryl 500
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2003to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalization into a geriatric care unit
- age > 70 years
- C reactive protein > 30 mg/l
- 25 < albumin < 35 g/l
- 130 < Na < 145 mmol/l
- BMI < 22
- weight loss > 10 % within the last 6 months
- MNA < 23.5
Who cannot join
- diabetes mellitus
- severe digestive failure
- enteral or parenteral nutrition
- renal,cardiac or digestive failure
- lactose intolerance
- terminal phase severe pathology
- MMS < 15
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Georges Clemenceau
Champcueil, 91750
Hopital Emile Roux
Limeil-Brévannes, 94456
Hopital Charles RICHET
Villiers-le-Bel, 95400
About this study
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients
- Conditions
- Denutrition
- Being tested
- Renutryl 500, Generique, Generique + Renutryl 500
- Keywords
- elderly people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renutryl 500Dietary supplement
GeneriqueDietary supplement
Generique + Renutryl 500Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| I | No intervention | Not described |
| II | Active comparator | oral nutrition Receives: Dietary Supplement: Renutryl 500 |
| III | Experimental | oral nutrition Receives: Dietary Supplement: Generique |
| IV | Experimental | oral nutrition Receives: Dietary Supplement: Generique + Renutryl 500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Risk Index
Measured: At J0, J21, J42
Secondary outcomes (2)
Measure of body mass index (BMI), Mini Nutritional Assessment, Fat mass,lean mass, serum albumin and transthyretin,Activities of Daily Living (ADL), ingesta and morbidity.
Tolerance
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startOct 2003
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DenutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Aussel, PhD, Study director, University PARIS V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560729
- Sponsor's protocol ID
- NCNF 0402
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2007
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
- ClinicalTrials.gov ID
- NCT00560729
- Acronym / sponsor ID
- NCNF 0402
- Conditions
- Denutrition
- Keywords
- elderly people
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | No intervention | – |
| II | Active comparator | Dietary Supplement: Renutryl 500oral nutrition |
| III | Experimental | Dietary Supplement: Generiqueoral nutrition |
| IV | Experimental | Dietary Supplement: Generique + Renutryl 500oral nutrition |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Hospitalization into a geriatric care unit
- age > 70 years
- C reactive protein > 30 mg/l
- 25 < albumin < 35 g/l
- 130 < Na < 145 mmol/l
Key exclusion criteria (7 listed)
- diabetes mellitus
- severe digestive failure
- enteral or parenteral nutrition
- renal,cardiac or digestive failure
- lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renutryl 500 | Dietary supplement | II |
| Generique | Dietary supplement | III |
| Generique + Renutryl 500 | Dietary supplement | IV |
Primary outcome
Nutritional Risk Index
Time frame: At J0, J21, J42
2 secondary outcomes
Measure of body mass index (BMI), Mini Nutritional Assessment, Fat mass,lean mass, serum albumin and transthyretin,Activities of Daily Living (ADL), ingesta and morbidity.
Tolerance
Time frame: Daily
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Aussel, PhD study director
University PARIS V
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renutryl 500, Generique and Generique + Renutryl 500 in people with Denutrition, run by Société des Produits Nestlé (SPN) at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Risk Index (time frame: At J0, J21, J42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.