Association Between Breastfeeding and Likelihood of Myopia in 6-7 Years Old Children

This study has been completed.
Sponsor:
Information provided by:
National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01013493
First received: November 12, 2009
Last updated: December 1, 2009
Last verified: December 2009
  Purpose

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.


Condition
Myopia
Nearsightedness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Association Between Breastfeeding and Likelihood of Myopia in 6-7 Years Old Children

Resource links provided by NLM:


Further study details as provided by National Nutrition and Food Technology Institute:

Enrollment: 245
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
myopic
non myope-healthy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

Inclusion criteria for case group subjects:

  • 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.

Inclusion criteria for control group subjects:

  • Subjects must be 6-7 years old
  • Subjects must graduate in grade, class and elementary school which case subjects is graduating in.

Exclusion Criteria:

Exclusion criteria for case group subjects:

  • 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.

Exclusion criteria for control group subjects:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013493

Locations
Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute (NNFTRI)
Tehran, Iran, Islamic Republic of, 1981619573
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
Principal Investigator: Amin Salehi Abargouei, M.S Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran
Study Chair: Naser Kalantari, Pediatrist Faculty of Nutrition Sciences and Food Technology, Sh. Beheshti University of Medical Sciences and Health Services, Tehran, Iran
  More Information

No publications provided

Responsible Party: Amin Salehi Abargouei, SBMU, National Nutrition and Food Technology Research Institute (NNFTRI)
ClinicalTrials.gov Identifier: NCT01013493     History of Changes
Other Study ID Numbers: 292
Study First Received: November 12, 2009
Last Updated: December 1, 2009
Health Authority: Islamic Republic of Iran: National Nutrition and Food Technology Institute

Keywords provided by National Nutrition and Food Technology Institute:
breastfeeding
myopia
nearsightedness
children

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 10, 2014