Evaluating the effect of snack fortified with vitamin D, iron, zinc and arginine compared with conventional snack on the anthropometric indices of malnourished children
This study was conducted in elementary boys' school in Shiraz. Following selection of qualified individuals, the complete study process was explained to the parents and written informed consent was obtained. All subjects entered to a 2-week run-in period before intervention to obtain detailed information about the dietary intakes and physical activity. At the end of run-in period participants were randomly assigned to receive either 1 servings/day (2200 ml/day) of fortified snack or 1 servings/day (200 ml/day) of conventional snack for 90 days. Anthropometric indices and biochemical assessment were done at the beginning and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged between 6 and 10 years;
Children with a weight for age chart below the 5th percentile;
Children whose parents have completed the informed consent form;
Non inclusion criteria: Serious medical illnesses including neurological, cancer, thyroid, cardiovascular, gastrointestinal, endocrineو renal, hepatic and eating disorders; Intake of medications that could affect body weight, appetite, vitamin D, zinc and iron metabolism
Intervention groups
Control group: receiving snack without fortification.
Intervention group: receiving snack fortified with arginine, zinc, iron, vitamin D.
Main outcome variables
Weight for age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181204041843N1
Registration date:2019-01-25, 1397/11/05
Registration timing:retrospective
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
Seyed Mohammad Aqaeinezhad Rudbane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
aqaeinezhad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-21, 1397/06/30
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of snack fortified with vitamin D, iron, zinc and arginine compared with conventional snack on the anthropometric indices of malnourished children
Public title
The effect of snacks fortified with vitamin D, iron, zinc and L-arginine on malnutrition
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 6 and 10 years
Children with a weight for age chart below the 5th percentile
Children whose parents have completed the informed consent form
Exclusion criteria:
Serious medical illnesses including neurologic, cancer, thyroid, cardiovascular, gastrointestinal, endocrine, renal, hepatic and eating disorders
Children with long-term short stature
Intake of medications that could affect body weight, appetite, vitamin D, zinc and iron metabolism
Participation in any other weight management studies within the last 6 months
Taking multivitamin-mineral supplements and other food supplements
Age
From 6 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly allocated into two groups of control and intervention using blocked randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and investigators will be blinded by the use of the same-shape package of snacks to both groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
IR.SUMS.REC.1396.163
Health conditions studied
1
Description of health condition studied
Malnutrition
ICD-10 code
E44
ICD-10 code description
Protein-calorie malnutrition of moderate and mild degree
Primary outcomes
1
Description
Weight for age
Timepoint
Before intervention, after intervention
Method of measurement
Digital scale
Secondary outcomes
1
Description
25 (OH)vit D
Timepoint
Before intervention, after intervention
Method of measurement
ELISA
2
Description
Serum Ferritin
Timepoint
Before intervention, after intervention
Method of measurement
ELISA
3
Description
Serum iron
Timepoint
Before intervention, after intervention
Method of measurement
Spectrophotometry
4
Description
Albumin
Timepoint
Before intervention, after intervention
Method of measurement
Laboratory measurement
5
Description
Serum transferrin
Timepoint
Before intervention, after intervention
Method of measurement
Laboratory measurement
6
Description
Serum Zinc
Timepoint
Before intervention, after intervention
Method of measurement
Laboratory measurement
7
Description
Serum IGF-1
Timepoint
Before intervention, after intervention
Method of measurement
Laboratory measurement
8
Description
Anthropometric indices (weight, Height, BMI)
Timepoint
Before intervention, after intervention
Method of measurement
Digital scales
Intervention groups
1
Description
Intervention group: Daily intake of 200 ml of dairy snack fortified with 5 g of arginine, 4 g of zinc, 4 g of iron and 500 units of vitamin D for 90 days.
Category
Treatment - Other
2
Description
Control group: Daily intake of 200 ml of regular snack (no fortification) for 90 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary Schools in Shiraz
Full name of responsible person
Seyed Mohammad Aqaeinezhad
Street address
Department of Education in Shiraz, Eeast Moadel street
City
Shiraz
Province
Fars
Postal code
7134785475
Phone
+98 71 3233 5953
Email
farsmedu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mostafavipour (Vice Chancellor for Education, Shiraz University of Medical Sciences)
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 2093
Email
madopzsh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Aqaeinezhad
Position
Ph.D. Candidate of Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Email
aqaeinezhad@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Position
Assistant Professor in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Email
jafaris@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Aqaeinezhad
Position
Ph.D. Candidate in Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Email
aqaeinezhad@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD