Low appetite is one of the most health and medical problems which affects many of children over the world and leads to failure in growth, lowering mental and physical activities, and reducing academic and life quality. Low appetite has various reasons but poor appetite in children is mostly due to nutritional deficiencies on one side and urine infections and gastrointestinal parasites on the other. The objective of this study is to examine effect of multivitamin-mineral supplement on children appetite and growth. After getting consent from parents, children with poor appetite will be examined for urine and stool infections. Those who their tests are normal will be recruited in the study. The number of 108 children will be divided in two, control and supplement, groups. Multivitamin in the form of syrup (10 ml) plus folic acid in the form of tablet (0.5 mg) will be given to children for 2 months. In control group children will receive placebo instead of supplements. After 2 months, medications will be discontinued and for one month children will be followed up. Appetite status, food intake and growth condition will be assessed before, at the end, and one month after intervention. The data of the beginning and at final will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070510190N1
Registration date:2012-09-04, 1391/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-04, 1391/06/14
Registrant information
Name
Masoumeh Akhlaghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 7288
Email address
akhlaghi_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-09-21, 1390/06/30
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing effect of multivitamin-mineral supplement on improvement of appetite in 3-7 years old children
Public title
Effect of multi-vitamin-mineral supplement on improvement of appetite in 3-7 years old children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children of 3-7 years old coming to Emam Reza and Nader Kazemi paraclinics, Shiraz, Iran, whose appetite is low or very low according to their parents claim; they should have negative urine and stool infection and parasite tests; A written consent will be taken before the children are recruited to the study. Exclusion criteria: children whose urine and feces tests are positive regarding urinary infections and feces parasites; Children with gastrointestinal and liver diseases, mental retardation, physical disabilities, cardiac, respiratory, and renal problems, epilepsy, cancer, severe food allergies like celiac; children who consume nutritional supplements or medications which affect food intake, absorption, or utilization.
Age
From 3 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Helal Ahmar nearby, Zand Street
City
Shiraz
Postal code
Approval date
2011-12-29, 1390/10/08
Ethics committee reference number
CT-90-3063
Health conditions studied
1
Description of health condition studied
Low appetite
ICD-10 code
R63.0
ICD-10 code description
Loss of appetite
Primary outcomes
1
Description
Appetite
Timepoint
Before intervention, 2 months after start of intervention, 1 month after termination
Method of measurement
Ranking
2
Description
Weight
Timepoint
Before intervention, 2 months after start of intervention, 1 month after termination
Method of measurement
Scale
3
Description
Height
Timepoint
Before intervention, 2 months after start of intervention, 1 month after termination
Method of measurement
measuring tape
4
Description
Mid-arm circumference
Timepoint
Before intervention, 2 months after start of intervention, 1 month after termination
Method of measurement
measuring tape
5
Description
Food intake
Timepoint
Before intervention, 2 months after start of intervention, 1 month after termination
Method of measurement
24 food recall
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1) multivitamin-mineral syrup, 10 ml/day for 2 months
2) Folic acid tablet 0.5 mg/day for 2 months
Category
Treatment - Drugs
2
Description
Control group: placebo syrup + Placebo tablet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nader Kazemi paraclinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poustforush
Street address
Central Building, Zand Street
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
Assistant Professor, Nutrition Faculty
Other areas of specialty/work
Street address
Razi Bluvard, College of Health and Nutriition
City
Shiraz
Postal code
Phone
+98 71 1725 7288
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
Assistant Professor, Nutrition Faculty
Other areas of specialty/work
Street address
College of Health and Nutrition, Razi Bluvard
City
Shiraz
Postal code
Phone
+98 71 1725 7288
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
Assistant Professor, Nutrition Faculty
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)