UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on blood concentrations of vitamins and trace elements and hair concentration of trace elemens in the patients receiving long-term home parenteral nutrition
Title of the study (Brief title)	A study on the concentrations of vitamins and trace elements in HPN patients
Region	Japan

Condition
Condition	Benign gastrointestinal diseases
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the required amounts of vitamins and trace elements, as well as the relations between nutritional status and trace element deficiencies in the patients receiving long-term home parenteral nutrition by measuring the blood trace element concentration, hair trace element concentration, and changes in the blood vitamin concentration and parameters related to nutritional status.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood concentrations of Fe, Zn, Cu, Mn, and Se. Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid. Hair concentration of trace elements
Key secondary outcomes	Blood concentrations of Fe, Zn, Cu, Mn, and Se. Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid. Hair concentration of trace elements

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with benign gastrointestinal diseases who meet the following criteria. 1. 20 years or older 2. Male or female 3. Able to provide written informed consent based on a complete understanding of the study requirements
Key exclusion criteria	Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigator
Target sample size	6

Research contact person
Name of lead principal investigator	Naohiro Washizawa
Organization	Toho University Medical Center Omori Hospital
Division name	Nutrition Therapy Center
Address	Omori-Nishi6-11-1,Ota-ku,Tokyo
TEL	03-3762-4151
Email	washi@med.toho-u.ac.jp

Public contact
Name of contact person	Naohiro Washizawa
Organization	Toho University Medical Center Omori Hospital
Division name	Nutrition Therapy Center
Address	Omori-Nishi6-11-1,Ota-ku,Tokyo
TEL	03-3762-4151
Homepage URL
Email	washi@med.toho-u.ac.jp

Sponsor
Institute	Toho University Medical Center Omori Hospital
Institute
Department

Funding Source
Organization	Toho niversity
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東邦大学医療センター大森病院

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 06 Month 20 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 03 Month 01 Day
Date trial data considered complete	2013 Year 03 Month 01 Day
Date analysis concluded	2013 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nutritional assessment with anthropometry. Blood concentrations of Fe, Zn, Cu, Mn, and Se.Serum concentration of ferritin, VB1, VB6, VC, VK, and folic acid.Hair concentration of trace elements.Serum concentration of total protein,albumin,choline esterase, total cholesterol,fatty acid fraction in blood C-reactive protein.

Management information
Registered date	2011 Year 06 Month 20 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006699