WoundsNCT02146612
Amino Acid Usage Patterns in Daily Practice
An observational study of Wounds and Lean Body Mass, run by Abbott Nutrition at 18 sites in Turkey (Türkiye).
Trial summary
The present study aims to evaluate the patient profile including medical conditions who use a nutritional supplement along with a balanced and varied diet in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds, Lean Body Mass
- What is being tested?
- Amino Acid Supplement Group
- How many people
- 354 participants
- Where
- 18 sitesTurkey (Türkiye)
- Study dates
- Dec 2012to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects receiving amino acid supplement prior to enrollment
Who may be able to join
- Age ≥ 18 years old.
- Consuming amino acid containing oral nutritional supplement before enrolment for malnutrition for hard-to-heal wounds or malnutrition due to primary disease.
- Followed by internal medicine or surgery departments.
Who cannot join
- History of allergy or hypersensitive reaction to any ingredient in the amino acid containing oral nutritional supplement.
- History of any food allergy or intolerance
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Turkey (Türkiye)18 sites
Adana Numune Eğitim ve Araştırma Hastanesi
Adana
Çukurova Üniversitesi Tıp Fakültesi
Adana
ANKARA ATATÜRK Eğitim ve Araştırma Hastanesi
Ankara
Ankara Numune Eğitim ve Araştırma Hastanesi
Ankara
Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
Ankara
Gazi Üniversitesi Tıp Fakültesi
Ankara
Bursa Çekirge Devlet Hastanesi
Bursa
Uludağ Üniversitesi Tıp Fakültesi
Bursa
Acıbadem Eskişehir Hospital
Eskişehir
Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
Istanbul
GÜLHANE ASKERİ TIP AKADEMİSİ - İstanbul
Istanbul
İstanbul Üniversitesi İstanbul Tıp Fakültesi
Istanbul
T.C.Bezmiâlem Vakıf Üniversitesi Tıp Fakültesi Hastanesi
Istanbul
Dr. Suat Seren Gogus Hastaliklari Hastanesi
Izmir
Ege Üniversitesi Tıp Fakültesi
Izmir
Erciyes Üniversitesi Tıp Fakültesi
Kayseri
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun
Karadeniz Teknik Üniversitesi Tıp Fakültesi
Trabzon
About this study
Official title: An Observational Study to Evaluate Amino Acid Usage Patterns in Daily Practice
The present study aims to evaluate the patient profile including medical conditions who use a nutritional supplement along with a balanced and varied diet in Turkey.
- Conditions
- Wounds, Lean Body Mass
- Being tested
- Amino Acid Supplement Group
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid Supplement GroupOther
Group receiving nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Group Receiving Supplement | Amino acid supplement group Receives: Other: Amino Acid Supplement Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of Medical Conditions
Diagnosis information
Measured: Baseline
Secondary outcomes (3)
Intake of Amino Acid containing Nutrition Supplement
Measured: Baseline and Week 8
Anthropometrics
weight, BMI
Measured: Change from Baseline to Week 8
Laboratory Parameters
Pre-albumin/Albumin
Measured: Change from Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tahsin Ozcagli, MD, Study chair, Abbott Nutrition Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146612
- Sponsor's protocol ID
- ANTK1202
- Status last verified
- May 2014
- First submitted
- 24 Apr 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate Amino Acid Usage Patterns in Daily Practice
- ClinicalTrials.gov ID
- NCT02146612
- Acronym / sponsor ID
- ANTK1202
- Conditions
- Wounds, Lean Body Mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 May 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 present study aims to evaluate the patient profile including medical conditions who use a nutritional supplement along with a balanced and varied diet in Turkey.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Supplement | – | Other: Amino Acid Supplement GroupAmino acid supplement group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving amino acid supplement prior to enrollment
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Consuming amino acid containing oral nutritional supplement before enrolment for malnutrition for hard-to-heal wounds or malnutrition due to primary disease.
- Followed by internal medicine or surgery departments.
Key exclusion criteria (2 listed)
- History of allergy or hypersensitive reaction to any ingredient in the amino acid containing oral nutritional supplement.
- History of any food allergy or 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 |
|---|---|---|
| Amino Acid Supplement GroupGroup receiving nutritional supplement | Other | Group Receiving Supplement |
Primary outcome
Frequencies of Medical Conditions
Time frame: Baseline
Diagnosis information
3 secondary outcomes
Intake of Amino Acid containing Nutrition Supplement
Time frame: Baseline and Week 8
Anthropometrics
Time frame: Change from Baseline to Week 8
Laboratory Parameters
Time frame: Change from Baseline to Week 8
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 26 May 2014.
Related trials for Wounds
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
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.
Tahsin Ozcagli, MD study chair
Abbott Nutrition Turkey
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Lean Body Mass, run by Abbott Nutrition at 18 sites in Turkey (Türkiye).
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 3 inclusion and 2 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Turkey (Türkiye). 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?
Frequencies of Medical Conditions (time frame: Baseline). 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 26 May 2014.