Zinc deficiency is one of the most important problems in society.This element is involved in the improvement of students cognitive activities and observed in the Former hippocampus of the brain and it deeply affect memory.with attention to The proven role of the zinc in the processes of cognitin and learning and Considering the fact that children with Down syndrome due to their disability that they suffer from, they are not able to take advantage of their ability in school. So The aim of this study was to evaluate the effect of zinc supplementation on the academic abilities of students with Down syndrome. The study included 44 male and female students with Down syndrome who are studying in special schools of Tehran. they will randomly selected. This study is double-blind. the case-study group will receive 20mg of Zinc gluconate daily, and control group will receive 20mg of placebo for 8 weeks daily .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405105670N9
Registration date:2015-09-07, 1394/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Private funding resource, or probably some resources allocate from Tabriz Medical Science university as a research project.
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on education performance of children with Down syndrome in Tehran
Public title
Effect of zinc supplementation on education performance of children with Down syndrome in Tehran
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 7 to 15 years old children with Down syndrome who are studying in special schools in Tehran.
Agreement to participate in the study:
normal diet and mixed eating habits
Criteria for excluding: receiving food supplements containing zinc since 6 months ago
any history of disease(Hypothyroidism, epilepsy, heart disease,..)
Any abnormal physiological and metabolic disease,Physical problems, organ defects, genetic abnormalities and visible disability
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Department of Tabriz University of Medical Sciences
Street address
3rd floor, Central Building #2, Tabriz University of Medical Sciences, Golgasht street,
City
Tabriz
Postal code
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
92230
Health conditions studied
1
Description of health condition studied
Down Syndrome
ICD-10 code
Q90
ICD-10 code description
Down Syndrome
Primary outcomes
1
Description
Cognitive Actvities
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
Wechsler scale-4
2
Description
Educational performance
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
Wechsler scale-4
Secondary outcomes
1
Description
Hair Zinc level
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
ppm with flame atomic absorption spectrometry
2
Description
Food intake
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
24-hours recall for 3 sequential days
Intervention groups
1
Description
Participant will receive 20 ml syrup containing 20 mg of zinc daily, for 8 weeks in the form of zinc gluconate syrup receive. Supplements should be taken between meals
Category
Treatment - Drugs
2
Description
for 8 weeks, participants will receive 20 ml syrup containing 20 mg placebo (starch syrup) daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Special school
Full name of responsible person
Zohreh Siyahpoush
Street address
Enqlab Eslami Educational complex, School station, Moalem Blvd, Yaft abad Street
City
Tehran
2
Recruitment center
Name of recruitment center
Ershad Special school
Full name of responsible person
Zohreh Siyahpoush
Street address
Nasim St, Patrice Lumumba St, Gisha St
City
Tehran
3
Recruitment center
Name of recruitment center
Zakerin Special school
Full name of responsible person
Zohreh Siyahpoush
Street address
Enqlab Eslami Educational complex, School station, Moalem Blvd, Yaft abad Street