Protocol summary

Summary
Objective: To determine the effect of supplement containing hydrolyzed collagen and compared with the same composition has on wound healing in patients with TBSA 30-20 percent .soy flour can be used as a supplement in critical condition. ِdesine: Target population: 30 men under 70 years, 30-20TBSA burns, body mass index over 18, insensitivity to yogurt clinical trial is a double blind samples randomly divided into control and intervention.procedure: Korerry formula of 1,000 calories, total calories in the form of supplements was evaluated. 4 snack in the intervention group: supplement containing hydrolyzed collagen protein-based bovine, yogurt, sugar and control formulations are matched based on soy flour is heated, yogurt and sugar in 4 snack will be feeding.although supplements prepare by third person .Exclusion criteria: people with underlying conditions that prohibit the consumption of high-calorie, high-protein diet, such as diabetes, kidney and liver disease, addiction, respiratory disease and those with BMI less than 18% . During the study period of 60 days (30 days in hospital and 30-day follow-up). All calories and macro nutrients include carbohydrates, protein and fat are absolutely identical in both groups.Primary outcome measure: Before feeding, 15 and 30 of the fairy albumin ; weight and Arm circumference are recorded. Photo taken ulcer. . According to the effects of collagen hydrolyze in the formulation will be evaluated on wound healing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011015536N5
Registration date: 2017-02-20, 1395/12/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,Tehran University of Medical sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2019-01-31, 1397/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of high-protein high-calorie supplement - based with ”Collagen Hydrolisate” with soya flour supplement on wound healing in patients with 20-30 percent burns : controlled double blind clinical trial
Public title
Effects of high-protein high-calorie supplement -content ”Collagen Hydrolysate” on wound healing in burns
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: Patients (men); less than 70 years; body mass index higher than 18; TBSA 30-20 burns Exclusion criteria: patients with underlying conditions that prohibit the consumption of high-calorie- high-protein diet such as: diabetes; kidney disease; liver disorders; addiction; respiratory disease; those with BMI less than 18 and people who are allergic to yogurt
Age
From 20 years old to 69 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, using a table of random numbers of groups are divided into two groups.Intervention and control.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical science
Street address
6th floor Ghods street Keshavarz Bolivar
City
Tehran
Postal code
-
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.TUMS.VCR.REC.1395.848

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk

Primary outcomes

1

Description
pre Albomin
Timepoint
befor intervention: 15days after intervention and 30days after intervention
Method of measurement
Blood test in torbidometri method

2

Description
photography
Timepoint
befor intervention: 15days after intervention and 30days after intervention
Method of measurement
SONY camera measuring the size of wound in cm

3

Description
weight
Timepoint
befor intervention: 15days after intervention and 30days after intervention
Method of measurement
scale

4

Description
Length of hospital stay
Timepoint
befor intervention: 15days after intervention and 30days after intervention
Method of measurement
Medical history folder

Secondary outcomes

1

Description
Arm circumference
Timepoint
befor intervention day 15 and 30
Method of measurement
meter

Intervention groups

1

Description
Intervention group:supplement include: yogurt (3.5% fat), Gelatin" Amootiya" and sugar. with calories and fat, protein,Fat and carbohydrate quite similar to the placebo group for 30 days and 4 snack per day would be given to patients and It prepare by third person.
Category
Placebo

2

Description
Control group: placebo include: yogurt(3.5% fat), heated soy flour and sugar. with calories and fat, protein and carbohydrate quite similar to the intervention group for 30 days and 4 snack per day would be given to patients and It prepare by third person.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Burn hospital
Full name of responsible person
Dr RezaVaghardoost
Street address
Yasemi street Zafar station Valiasr Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for ResearchTehran University of Medical sciences
Full name of responsible person
Deputy of research and technology medical University Tehran
Street address
Room No 605 sixth flooor Ghods stirt Keahvarz Bolivar
City
TEHRAN
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for ResearchTehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences Department of Nutrition and Dietetic
Full name of responsible person
Mohamad javad Hosseinzadeh
Position
MD PHD Clinical nutrition
Other areas of specialty/work
Street address
No 44.Hojat dust aven.Naderi street Keshavarz bolivar
City
Tehran
Postal code
Phone
+98 21 8895 5975
Fax
Email
hosseinzadeh.md.phd@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
school of Nutritional sciences and dieteticsTUMS
Full name of responsible person
mohammad Javad Hosseinzadeh
Position
MD PHD Of chlinical nutrition
Other areas of specialty/work
Street address
Hojatdoost st.Naderi Ave,Keshavarz Blv
City
TEHRAN
Postal code
Phone
+98 218893059
Fax
+98 21 8898 4861
Email
mhosseinzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medicin Tehran University
Full name of responsible person
Katayoun Bagheri miyab
Position
Master student of Nutrition indisaster
Other areas of specialty/work
Street address
No 44,Hojat Doost Ave,Naderi St,Keshavarz Bolv.
City
TEHRAN
Postal code
Phone
00
Fax
Email
ka_bagheri@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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