NCT01013493

Brief Summary

Myopia is the main reason of vision loss in the world which is seen in 30.4 million adults in USA (1). In a myopic eye, images are focused in front of retina because, cornea and crystalline lens become more powerful in focusing the image or the eye axis become too long (axial myopia) (2). Myopia prevalence in adolescents has been raised in recent years and nowadays it has reached to 10-25% and 60-80% in western and eastern countries respectively (3). Tehran eye study showed that the prevalence of myopia in Tehran is 21.8% and 17.2% based on manifest and cycloplegic refraction respectively (4). One study in Dezful, Iran showed that 3.7% of 7-15 years old children are myopic (5). Today potential role of early life nutrition in myopia development in later life is becoming an attractive field of study. It has been shown that until weaning; breast milk is the main source of many nutrients \[such as docosahexaenoic acid (DHA)\] which are important for photoreceptors and cortical neuronal development (6). But results about the relationship between breastfeeding and likelihood of childhood myopia are controversial. A hypothesis-generating study (7) showed an independent and inverse relationship between breastfeeding and likelihood of myopia in 10-12 year old Singaporean children. However, data pulled from three English birth cohorts done in 10-11y and 15-16y children did not show any effect (8). To examine the association between breastfeeding pattern and likelihood of myopia in 6-7y children, a retrospective case-control study is designed in National Nutrition and Food Technology research Institute of Iran. This study will try to assess breastfeeding pattern and almost all cofactors which may relate to myopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

6 months

First QC Date

November 12, 2009

Last Update Submit

December 1, 2009

Conditions

Keywords

breastfeedingmyopianearsightednesschildren

Study Arms (2)

myopic

non myope-healthy

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study is a retrospective case-control trial, in which subjects for case and control groups will be chosen based on inclusion and exclusion criteria, from 6-7 years old school children living in north Tehran.

You may qualify if:

  • Subjects must be 6-7 years old
  • Subjects must have myopia with or without astigmatism and the time period between diagnosis of myopia and recruiting the subjects must not be more than 6 months.
  • Subject must be graduating in grade 1 in one of north Tehran elementary schools.
  • Subject and their parents must have tendency to participate in this study.
  • Subjects must be 6-7 years old
  • Subjects must graduate in grade, class and elementary school which case subjects is graduating in.

You may not qualify if:

  • Subjects must not have any eye disorder other than myopia with or without astigmatism
  • Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
  • Subjects must not have any eye disorder
  • Subjects must not have any metabolic or congenital disorder which has relationship with myopia.
  • Subjects must not go on diet for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute (NNFTRI)

Tehran, Tehran Province, 1981619573, Iran

Location

MeSH Terms

Conditions

MyopiaBreast Feeding

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesFeeding BehaviorBehavior

Study Officials

  • Amin Salehi Abargouei, M.S

    Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran

    PRINCIPAL INVESTIGATOR
  • Naser Kalantari, Pediatrist

    Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations