MalnutritionOFOSNCT02102009
Nutritional Supplementation in Adults With Chronic Respiratory Disease
A study testing Complete enteral formula and Dietary Advise in people with Malnutrition and Pulmonary Disease, Chronic Obstructive, run by Laboratorios Ordesa at 1 site in Peru.
Trial summary
The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Complete enteral formula and Dietary Advise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 sitePeru
- Study dates
- Apr 2014to May 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years.
- Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient.
- Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD).
- Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men).
- Patients who signed informed consent.
Who cannot join
- Clinically unstable patients.
- Patients requiring other nutritional supplements or parenteral nutrition.
- Patients diagnosed with active pulmonary tuberculosis.
- Patients with acute respiratory failure.
- Patients with immunosuppression (including HIV, diabetes or neoplasms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..
The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.
Read the detailed description
This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.
- Conditions
- Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive
- Being tested
- Complete enteral formula, Dietary Advise
- Keywords
- Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD
- Medical subject headings
- Malnutrition, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete enteral formulaDietary supplement
Also called Vitafos, Vitafos Adultos, Vitafos Vainilla
Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product).
Time of intervention: 3 months.
Dietary AdviseOther
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
| Study group | Role | What they receive |
|---|---|---|
| Vitafos | Experimental | Complete enteral formula Receives: Dietary Supplement: Complete enteral formula |
| Dietary Advise | Active comparator | Dietary advise according to the hospital routine clinical practice. Receives: Other: Dietary Advise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nutritional status
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Measured: At hospital discharge or at 1th month and at 3 months
Changes in pulmonary function
Differences in forced expiratory volume measured by spirometry.
Measured: At 3rd month
Secondary outcomes (5)
Respiratory Infections
Differences measured by number of infections and hospital readmission rate.
Measured: At 1st, 2nd, 3rd month
Muscular Strength
Differences measured by hand-grip strength.
Measured: At 3rd month.
Exercise Tolerance
Differences measured by six minutes walk test.
Measured: At 3th month
Quality of Life of the participants
Differences measured by Saint George respiratory questionnaire.
Measured: At hospital discharge or 1st month and 3rd month
Tolerability of the product
Measured by gastrointestinal discomfort and product compliance.
Measured: At 1st, 2nd and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peruvian Clinical Research
- Responsible party
- Sponsor
- Investigators
- Marco Antonio Camere Torrealva, Doctor, Principal investigator, Clínica San Gabriel - Perú
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102009
- Sponsor's protocol ID
- OFOS-01-012
- Acronym
- OFOS
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..
- ClinicalTrials.gov ID
- NCT02102009
- Acronym / sponsor ID
- OFOS / OFOS-01-012
- Conditions
- Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive
- Keywords
- Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Peruvian Clinical Research
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Apr 2014 (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.
The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.
Detailed description
This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitafos | Experimental | Dietary Supplement: Complete enteral formulaComplete enteral formula |
| Dietary Advise | Active comparator | Other: Dietary AdviseDietary advise according to the hospital routine clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 80 years.
- Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient.
- Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD).
- Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men).
- Patients who signed informed consent.
Key exclusion criteria (5 listed)
- Clinically unstable patients.
- Patients requiring other nutritional supplements or parenteral nutrition.
- Patients diagnosed with active pulmonary tuberculosis.
- Patients with acute respiratory failure.
- Patients with immunosuppression (including HIV, diabetes or neoplasms).
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 |
|---|---|---|
| Complete enteral formulaAlso: Vitafos, Vitafos Adultos, Vitafos VainillaProduct: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product). Time of intervention: 3 months. | Dietary supplement | Vitafos |
| Dietary AdvisePatients will receive the usual dietary advise in these patients according hospital clinical practice . | Other | Dietary Advise |
Primary outcome
Changes in nutritional status
Time frame: At hospital discharge or at 1th month and at 3 months
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Changes in pulmonary function
Time frame: At 3rd month
Differences in forced expiratory volume measured by spirometry.
5 secondary outcomes
Respiratory Infections
Time frame: At 1st, 2nd, 3rd month
Muscular Strength
Time frame: At 3rd month.
Exercise Tolerance
Time frame: At 3th month
Quality of Life of the participants
Time frame: At hospital discharge or 1st month and 3rd month
Tolerability of the product
Time frame: At 1st, 2nd and 3rd months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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.
Marco Antonio Camere Torrealva, Doctor principal investigator
Clínica San Gabriel - Perú
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete enteral formula and Dietary Advise in people with Malnutrition and Pulmonary Disease, Chronic Obstructive, run by Laboratorios Ordesa at 1 site in Peru.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in nutritional status (time frame: At hospital discharge or at 1th month and at 3 months). 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 19 Jul 2019.