NCT02038504

Brief Summary

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

January 10, 2014

Last Update Submit

June 27, 2014

Conditions

Gastrointestinal Fistula

Keywords

gastrointestinal fistulaenteral nutritionthyroid function

Outcome Measures

Primary Outcomes (1)

  • Thyroid function

    Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index

    Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.

Study Arms (1)

gastrointestinal fistula

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Department of general surgery in Jinling hospital

You may qualify if:

  • Clinical diagnosis of gastrointestinal fistula
  • Clinical diagnosis of nonthyroidal illness syndrome
  • Using enteral nutrition for fistula management

You may not qualify if:

  • patients who were prescribed drug which may affect thyroid function before or in our study
  • patients who were diagnosed as primary thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Jinling Hospital

Nanjing, Jiangsu, 210000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Digestive System Fistula

Condition Hierarchy (Ancestors)

Digestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VIce-president of General Surgery, Jinling Hospital, Professor of Medical School of Nanjing University

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 16, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

CN(1)