Protocol summary

Summary
This study is a randomized controlled clinical trial, and 106 children will be studied for eight weeks. Inclusion criteria are having age 24 to 59 months; mild and moderate malnutrition without edema (Anthropometric index of weight for height between the -1 and -3 z-score); filling a consent form. Exclusion criteria are being twins; food allergies and intolerance; severe anemia; liver-kidney disease; malabsorption syndrome; unwillingness to cooperate. After enrollment, children will be allocated into two groups (Intervention and Control groups) based on random number table. Intervention group will receive the formula and the control group on the other will not. At baseline and during examination sessions, caregivers will be trained about Childhood nutrition. Before initiating the intervention, we will ask caregivers to give 5 grams of sample to children in the intervention group in case of checking for food intolerance. In absence of food intolerance, we will measure and record their weight, height and weight for height anthropometric index. In addition, during examination sessions, we will ask questions about the frequency of symptoms such as diarrhea, anorexia and abdominal pain. Also, we will take two Food records from caregivers which will show food consumed by children. After intervention we will measure and record their weight, height and weight for height anthropometric index. The primary outcome will be recovery (Increment of children's weight for height anthropometric index to the top of -1 z-score). The Secondary outcomes will be average increment of weight gain, height gain, and incidence of fever and diarrhea among children.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021315536N6
Registration date: 2017-04-07, 1396/01/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-07, 1396/01/18
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
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Ready-to-Use Supplementary Food 's impact on indicators of malnutrition in Mild and Moderately Wasted Children: a randomized controlled trial.
Public title
The Ready-to-Use Supplementary Food 's impact on indicators of Children malnutrition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having age 24 to 59 months; Mild and moderate malnutrition without edema (Anthropometric index of weight for height between the -1 and -3 z-score); Filling a consent form. Exclusion criteria: Being twins; Food allergies and intolerance; Severe anemia; Liver-kidney disease; Malabsorption syndrome; Lack of cooperation.
Age
From 2 years old to 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Children will be numbered, and randomly will be assigned into two groups (Control and Intervention groups) by random number tables.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
6th floor, Central Tehran University, Ghods street, Keshavarz Bolivar.
City
Tehran
Postal code
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TUMS.VCR.REC.1395.353

Health conditions studied

1

Description of health condition studied
moderate malnutrition
ICD-10 code
E44.0
ICD-10 code description
Moderate protein-energy malnutrition

2

Description of health condition studied
mild malnutrition
ICD-10 code
E44.1
ICD-10 code description
Mild protein-energy malnutrition

Primary outcomes

1

Description
recovery
Timepoint
Every two weeks after intervention
Method of measurement
Increase children's weight for height anthropometric index z-score to the top of -1 in weight-for-height tables Children's World Health Organization, Weight will be measured with scale, and height will be measured with meter.

Secondary outcomes

1

Description
weight gain
Timepoint
two month after intervention
Method of measurement
difference between New weight at the end of intervention and children's initial weight. Weight will be measured with scale.

2

Description
height gain
Timepoint
two month after intervention
Method of measurement
difference between New height at the end of intervention and children's initial height. height will be measured with meter.

3

Description
Fever
Timepoint
two month after intervention
Method of measurement
Counting the number of days of fever from the beginning to the end of the study. method of measurement is With question

4

Description
Diarrhea
Timepoint
two month after intervention
Method of measurement
Counting the number of days of Diarrhea from the beginning to the end of the study. . method of measurement is With question.

Intervention groups

1

Description
Control group: before and during intervention, in four half-hour sessions, caregivers will be trained about Childhood nutrition by face to face method. The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods.
Category
Treatment - Other

2

Description
Intervention group: The Ready-to-Use Supplementary Food, which contains whey protein, egg white, soy, palm, starch, honey, sugar, oil and natural flavorings will be given to children as daily snacks for eight weeks. On average, each of them should consume one to three packs (100 grams), daily. Like control group, before and during intervention, caregivers will be trained about Childhood nutrition by face to face education. The subjects of education sessions will be the adequacy of feeding; the correct number of meals; type and amount of food each meal should have, based on the child's age; sensory characteristics and diversity of food; hygiene; and how to prepare energetic nutritious foods.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Abolfazl (AS) Comprehensive Rural Health Service Center
Full name of responsible person
Fatemeh Azimi
Street address
Hazrat Abolfazl (AS) Comprehensive Rural Health Service Center, Shour abad, Qhom old road, Shahr Rey.
City
Tehran

2

Recruitment center
Name of recruitment center
Bagher Shahr Comprehensive Urban Health Service Center
Full name of responsible person
Fatemeh Azimi
Street address
Bagher Shahr Comprehensive Urban Health Service Center, No. 82, Next to gas operated, St. Shahid Ismaili, Bagher shahr, Shahr Rey.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr.Masood Younesian
Street address
Room No 605, sixth floor, Ghods street, Keshvarz Blvd
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 research of Tehran 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 dietetics TUMS
Full name of responsible person
Mohammad Javad Hosseinzadeh
Position
MD PHD Of chlinical nutrition
Other areas of specialty/work
Street address
No. 44, Hojatdoost st, Naderi Ave, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 218893059
Fax
Email
mhosseinzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Azimi
Position
MSc student of Nutrition Sciences in disaster
Other areas of specialty/work
Street address
No 44, Hojat Doost Ave, Naderi St, Keshavarz Bolv.
City
Tehran
Postal code
Phone
00
Fax
Email
fa.azm2012@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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