Evaluating the feasibility and effectiveness of zinc supplementation on height, weight and serum Ferritin amongst children aged 6-24 months in Pishva/Varamin and Damavand
purpose: to determine the feasibility and effectiveness of zinc supplementation on height, weight, serum zinc and its interaction with ferritin among 6-24 months old children in Damavand, Pishva and Varamin. Study design: The study was a double-blind field trial with placebo. Study population: 6-24 months old children in Damavand, Varamin and Pishva. Inclusion criteria: age range of 6-24 months; apparently healthy; agreed to participate in the study. Exclusion criteria: severe disease; rejection complementary sample size: 440 persons in both intervention and control groups is determined by random sampling. Intervention: Intervention: after explaining the aims and methods of implementation and signing an agreement, suspension of zinc and placebo given to mothers of children training on how and when to use. In monthly visit children's height and weight were measured. After that mothers receive the suspension of zinc and placebo again. 100 children in each group were randomly selected and sampled for determination of zinc and ferritin at the beginning and end of the intervention. food intake of children who participated in the serology part checked by using dietary recall questionnaire which completed by trained nutritionists with mothers or child care provider. Intervention time: 6 months out.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111519951N1
Registration date:2015-02-12, 1393/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Morteza Abdollahi
Name of organization / entity
National Nutrition And Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7485
Email address
m.abdollahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Department of Ministry of Health and Medical Education, UNICEF, National Nutrition and Food Technology Research Institute
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the feasibility and effectiveness of zinc supplementation on height, weight and serum Ferritin amongst children aged 6-24 months in Pishva/Varamin and Damavand
Public title
Efficacy of zinc supplementation among 6 months to 2 years old children on height and prevention of infectious diseases
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: age range 6-24 months; apparently healthy; agreement for participate in the study
exclusion criteria: with severe disease; rejection of the supplement
Age
From 6 months old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
880
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of National Nutrition and Food Technology Research Institute
Street address
No.7, West Arghavan st., Farahzadi Blvd., Qarb, Tehran-Iran
City
Tehran
Postal code
1981618573
Approval date
2014-10-07, 1393/07/15
Ethics committee reference number
053576
Health conditions studied
1
Description of health condition studied
zinc deficiency
ICD-10 code
E60
ICD-10 code description
Dietary zinc deficiency
Primary outcomes
1
Description
zinc level
Timepoint
at beginning and end of the intervention
Method of measurement
in percentage of mg in taken blood sample
2
Description
ferritin level
Timepoint
at beginning and end of the intervention
Method of measurement
in percentage of mg in taken blood sample
Secondary outcomes
1
Description
Height
Timepoint
monthly from beginning to end of the intervention
Method of measurement
in Cm measured by stadiometer
2
Description
Weight
Timepoint
monthly from beginning to end of the intervention
Method of measurement
In Kg measured by special weighing scale
Intervention groups
1
Description
zinc sulfate suspension 60 ML.
Category
Treatment - Drugs
2
Description
placebo suspension 60 ML
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Covered Population of Ministry of Health Shahid Beheshti University of Medical Science
Full name of responsible person
Fereshteh Fozouni
Street address
Ministry of Health Shahid Beheshti University of Medical Science, Former Building, Intersection between Jomhuri, Hafez, Hafez St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Department of Ministry of Health and Medical Education