NCT02146612

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

April 24, 2014

Last Update Submit

May 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequencies of Medical Conditions

    Diagnosis information

    Baseline

Secondary Outcomes (3)

  • Intake of Amino Acid containing Nutrition Supplement

    Baseline and Week 8

  • Anthropometrics

    Change from Baseline to Week 8

  • Laboratory Parameters

    Change from Baseline to Week 8

Study Arms (1)

Group Receiving Supplement

Amino acid supplement group

Other: Amino Acid Supplement Group

Interventions

Group receiving nutritional supplement

Group Receiving Supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects receiving amino acid supplement prior to enrollment

You may qualify if:

  • 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.

You may not qualify if:

  • History of allergy or hypersensitive reaction to any ingredient in the amino acid containing oral nutritional supplement.
  • History of any food allergy or intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Adana Numune Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

Location

Çukurova Üniversitesi Tıp Fakültesi

Adana, Turkey (Türkiye)

Location

ANKARA ATATÜRK Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Ankara Numune Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Gazi Üniversitesi Tıp Fakültesi

Ankara, Turkey (Türkiye)

Location

Bursa Çekirge Devlet Hastanesi

Bursa, Turkey (Türkiye)

Location

Uludağ Üniversitesi Tıp Fakültesi

Bursa, Turkey (Türkiye)

Location

Acıbadem Eskişehir Hospital

Eskişehir, Turkey (Türkiye)

Location

Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

GÜLHANE ASKERİ TIP AKADEMİSİ - İstanbul

Istanbul, Turkey (Türkiye)

Location

İstanbul Üniversitesi İstanbul Tıp Fakültesi

Istanbul, Turkey (Türkiye)

Location

T.C.Bezmiâlem Vakıf Üniversitesi Tıp Fakültesi Hastanesi

Istanbul, Turkey (Türkiye)

Location

Dr. Suat Seren Gogus Hastaliklari Hastanesi

Izmir, Turkey (Türkiye)

Location

Ege Üniversitesi Tıp Fakültesi

Izmir, Turkey (Türkiye)

Location

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, Turkey (Türkiye)

Location

Ondokuz Mayıs Üniversitesi Tıp Fakültesi

Samsun, Turkey (Türkiye)

Location

Karadeniz Teknik Üniversitesi Tıp Fakültesi

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Tahsin Ozcagli, MD

    Abbott Nutrition Turkey

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

May 26, 2014

Study Start

December 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations