Hip FracturesIRENENCT04183075
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
A study testing FontActiv Superprotein/Hypercaloric Fiber and Carbohydrates and C Vitamin in people with Hip Fractures and Malnutrition, run by Laboratorios Ordesa at 2 sites in Spain.
Trial summary
Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Malnutrition
- What is being tested?
- FontActiv Superprotein/Hypercaloric Fiber and Carbohydrates and C Vitamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2020to May 2021
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years old.
- Patients admitted to hospital by spontaneous hip fracture and requiring surgery.
- Patients who after hip intervention are included in rehabilitation protocols with outpatient rehabilitation plan.
- Patients who agree to participate by signing informed consent or their regular caregivers grant consent.
Who cannot join
- Patients who have a hip fracture from high-impact trauma or secondary to bone pathology (such as neoplasm).
- Patients with concomitant diseases such as severe hepatic impairment, severe renal impairment, insulin-dependent diabetes melitus and decompensated diabetes mellitus.
- Patients who require clinical stabilization before surgery beyond 72 hours.
- Patients receiving emergency surgery.
- Patients with previous prostheses.
- Patients with pacemakers.
- Patients who are not likely to complete the follow-up.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clínico de Málaga
Málaga, Andalusia, 29010
Jose Manuel Garcia Almeida, 951 03 20 00
Hospital Virgen del Rocío
Seville, Andalusia, 41013
Pedro Pablo Garcia Luna, 955 01 20 00
About this study
Official title: Clinical Trial to Assess the Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Elderly Patients With Spontaneous Hip Fracture
Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.
Read the detailed description
Hip fracture is a very prevalent pathology in the elderly population. It is estimated that 35-40% of people over 65 suffer a drop per year, and above 75 years this percentage is even higher, with hip fractures being one of the most serious consequences.With regard to malnutrition, the investigators know that aging carries an increased risk of suffering from decreased appetite and intake and changes in body composition. According to different series, the percentage of malnutrition in patients with hip fracture ranges from 13% to 60%. According to the hospital protocols in Spain in elderly people with spontaneous hip fracture, it is important to perform a nutritional screening during the first 24-48 hours of admission, to evaluate their nutritional status and apply a dietary treatment.
The IRENE study aims to determine whether phase angle and reactance, measured by electrical bioimpedance by vector analysis (BIVA) are related to functional recovery in patients with hip fracture.
- Conditions
- Hip Fractures, Malnutrition
- Being tested
- FontActiv Superprotein/Hypercaloric Fiber, Carbohydrates and C Vitamin
- Keywords
- phase angle, nutritional supplement
- Medical subject headings
- Hip Fractures, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FontActiv Superprotein/Hypercaloric FiberDietary supplement
The product under study has a liquid presentation, in 200 ml bottles, ready to take
Carbohydrates and C VitaminDietary supplement
The control product will be prepared with equal presentation and taste as similar as possible tan study product
| Study group | Role | What they receive |
|---|---|---|
| FontActiv Superprotein/Hypercaloric Fiber | Experimental | Full Nutritional Supplement Receives: Dietary Supplement: FontActiv Superprotein/Hypercaloric Fiber |
| Carbohydrates and C Vitamin | Active comparator | Nutritional Supplement Receives: Dietary Supplement: Carbohydrates and C Vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare changes in nutritional status between groups based on phase angle
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Measured: From baseline to month 4
Compare changes in nutritional status between groups based on force measurement
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).
Measured: From baseline to month 4
Secondary outcomes (8)
To compare functional recovery
Compare functional recovery using the Barthel Scale between patients taking nutritional supplement under study and placebo. It is scored on a scale ranging from 0 to 100, with 90 being the maximum score if the patient is in a wheelchair.
Measured: From baseline to month 4
To compare the morphological recovery by muscle ultrasound
Compare the morphological recovery valued by muscle ultrasound between patients taking nutritional supplement under study and placebo. Ultrasound performed at baseline and month 4
Measured: From baseline to month 4
To compare changes in Mini Nutrition Assessment test for aged people
Compare changes in the Mini Nutrition Assessment score between the two study groups. This is a validated test for aged people to assess the nutritional status. Good nutritional state: more than 17points. Bad nutritional state: less than 17 points.
Measured: From baseline to month 4
To compare the evolution of the Global Subjective Valuation questionnaire
To compare the evolution of the Global Subjective Valuation between the two study groups. It is a method designed to estimate nutritional status through medical history and physical examination. Each of the sections is valued as mild, moderate or severe, being severe the worst nutritional condition.
Measured: From baseline to month 4
Compare changes between groups in the Charlson index
Charlson index takes into account the number and severity of accompanying diseases to predict the risk of death. Each pathology that patient has, has a number. The higher the number, the worst prediction.
Measured: From baseline to month 4
Number of participants that have to be readmitted at the hospital.
Compare the difference in hospital re-admissions between the two study groups.
Measured: From baseline to month 4
Number of participants that die during the study
Compare the differences in mortality within four months of the start of the study between the two study groups
Measured: From baseline to month 4
Compare changes in the ratio RCP/Prealbumin index in the blood analysis
Compare changes in the ratio RCP/Prealbumin index between the two study groups.
Measured: From baseline to month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startSep 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Manuel Garcia Almeida, Principal investigator, Hospital Clínico de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183075
- Sponsor's protocol ID
- IRENE
- Acronym
- IRENE
- Status last verified
- Sep 2020
- First submitted
- 25 Nov 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Elderly Patients With Spontaneous Hip Fracture
- ClinicalTrials.gov ID
- NCT04183075
- Acronym / sponsor ID
- IRENE / IRENE
- Conditions
- Hip Fractures, Malnutrition
- Keywords
- phase angle, nutritional supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Dec 2019 (actual)
- 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.
Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.
Detailed description
Hip fracture is a very prevalent pathology in the elderly population. It is estimated that 35-40% of people over 65 suffer a drop per year, and above 75 years this percentage is even higher, with hip fractures being one of the most serious consequences.With regard to malnutrition, the investigators know that aging carries an increased risk of suffering from decreased appetite and intake and changes in body composition. According to different series, the percentage of malnutrition in patients with hip fracture ranges from 13% to 60%. According to the hospital protocols in Spain in elderly people with spontaneous hip fracture, it is important to perform a nutritional screening during the first 24-48 hours of admission, to evaluate their nutritional status and apply a dietary treatment.
The IRENE study aims to determine whether phase angle and reactance, measured by electrical bioimpedance by vector analysis (BIVA) are related to functional recovery in patients with hip fracture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FontActiv Superprotein/Hypercaloric Fiber | Experimental | Dietary Supplement: FontActiv Superprotein/Hypercaloric FiberFull Nutritional Supplement |
| Carbohydrates and C Vitamin | Active comparator | Dietary Supplement: Carbohydrates and C VitaminNutritional Supplement |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients over 65 years old.
- Patients admitted to hospital by spontaneous hip fracture and requiring surgery.
- Patients who after hip intervention are included in rehabilitation protocols with outpatient rehabilitation plan.
- Patients who agree to participate by signing informed consent or their regular caregivers grant consent.
Key exclusion criteria (7 listed)
- Patients who have a hip fracture from high-impact trauma or secondary to bone pathology (such as neoplasm).
- Patients with concomitant diseases such as severe hepatic impairment, severe renal impairment, insulin-dependent diabetes melitus and decompensated diabetes mellitus.
- Patients who require clinical stabilization before surgery beyond 72 hours.
- Patients receiving emergency surgery.
- Patients with previous prostheses.
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 |
|---|---|---|
| FontActiv Superprotein/Hypercaloric FiberThe product under study has a liquid presentation, in 200 ml bottles, ready to take | Dietary supplement | FontActiv Superprotein/Hypercaloric Fiber |
| Carbohydrates and C VitaminThe control product will be prepared with equal presentation and taste as similar as possible tan study product | Dietary supplement | Carbohydrates and C Vitamin |
Primary outcome
Compare changes in nutritional status between groups based on phase angle
Time frame: From baseline to month 4
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Compare changes in nutritional status between groups based on force measurement
Time frame: From baseline to month 4
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).
8 secondary outcomes
To compare functional recovery
Time frame: From baseline to month 4
To compare the morphological recovery by muscle ultrasound
Time frame: From baseline to month 4
To compare changes in Mini Nutrition Assessment test for aged people
Time frame: From baseline to month 4
To compare the evolution of the Global Subjective Valuation questionnaire
Time frame: From baseline to month 4
Compare changes between groups in the Charlson index
Time frame: From baseline to month 4
Number of participants that have to be readmitted at the hospital.
Time frame: From baseline to month 4
Number of participants that die during the study
Time frame: From baseline to month 4
Compare changes in the ratio RCP/Prealbumin index in the blood analysis
Time frame: From baseline to month 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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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.
Jose Manuel Garcia Almeida principal investigator
Hospital Clínico de Málaga
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FontActiv Superprotein/Hypercaloric Fiber and Carbohydrates and C Vitamin in people with Hip Fractures and Malnutrition, run by Laboratorios Ordesa at 2 sites in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roser De Castellar, MD (+34 902105243, RDeCastellar@ordesa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare changes in nutritional status between groups based on phase angle (time frame: From baseline to month 4). The study lists 2 primary outcomes in all. 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 18 Sep 2020.