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MyopiaNCT01013493

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

An observational study of Myopia and Nearsightedness, run by National Nutrition and Food Technology Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Nearsightedness
How many people
245 participants
Where
1 siteIran
Study dates
Sep 2008to Jun 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • National Nutrition and Food Technology Research Institute (NNFTRI)

    Tehran, Tehran Province, 1981619573

Other trials in Iran

About this study

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).

Read more

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.

Read the detailed description

For proper vision, eyes need to focus exactly on images. The two main determinants of refraction are focus power of cornea and the eye's axis length. In normal eyes, images are formed exactly on retina (emmetropia), but farsightedness (hyperopia) is the situation in which, the eye forms images in the backside of retina and nearsightedness (myopia) is a situation in which images are formed in front of retina, and it may have two reasons: 1) the lens convexity is more powerful than normal and 2) the eye axis is longer than normal (axial myopia).

Refractive errors are measured in diopter (D), and myopia is specified with a negative sign. Severity of myopia is categorized into 3 levels. 1) Mild (0 to -1.5D), 2) moderate (-1.5D to -6.0D) and 3) and severe myopia (-6.0D or above). Pathogenic myopia develops, when this condition advances to -8.0 D and above. Visual disorders - moderate retina disorders, cataract, and glaucoma - may be seen in patients with moderate and severe myopia. At birth, most infants are hyperopic but this condition lowers when they grow up and by the age 5-8, eyes must be emmetropic (normal and without any refractive error) (2).

Nearsightedness is seen in 30.4 million adults in USA (1). It's prevalence in adolescents is remarkably increased in last decades and today its prevalence in industrialized western and eastern societies are increased into 10-25 and 60-80 percent respectively (3). For American society, 60 percent of myopia can be categorized as early myopia (in childhood/school ages) which is usually in ages 9-11 years, and increases in adolescence years, and decreases in late adolescence and beginning of 20th decade of life, and usually stops at -3 to -4 D(9,10). A study in Tehran (4) showed that prevalence of myopia is 21.8 and 56.6 percent based on manifest and cycloplegic refraction respectively. Another study showed a high prevalence of myopia in schoolchildren from Kashan, Iran (11). Also a study in Dezful, Iran showed that prevalence of myopia in 7-15y and 14-18y children are 3.4 and 33 percent respectively (12).

Factors related to myopia can be divided into two groups: 1) hereditary and 2) environmental. Relationship between heredity and likelihood of myopia has been shown in many studies (13, 14). These studies obviously showed the effect of parental myopia on moderate levels of childhood myopia. Today different areas on several chromosomes are known for severe myopia (such like 18p, 12q, 7q36, TGIF) (15-17). Although it seems that two of these chromosomes (18q, 12q) do not have any relationship with childhood myopia (18).

Environmental factors which studies have shown that may be in relation with myopia are: near work (19, 20), stature (21, 22), night time light exposure (10) [however this relationship was not confirmed neither in American (20) and English children and nor in Indian monkeys (23, 24)], day time light exposure (25), refined sugar consumption [It has been shown that carbohydrate consumption can stimulate a series of events which lead to eye's axial length increase and consequently myopia. So refined sugar consumption which has been increased nowadays may play a role.] (26), IQ (Intelligence quotient) (27-33), birth weight, social and economic condition (7), physical activity (32), and breastfeeding (7).

Increasing prevalence of myopia, particularly in Asian urban children, confirms that life style in childhood and infancy may play a role (3). Today potential effect of early life nutrition on myopia development in later life is becoming an attractive field of study. Breastfeeding has been related to neural development which affects visual acuity. Up to weaning, breastfeeding is the main source of many micronutrients [including docosahexanoic acid (DHA)], which are important for light receptors and brain neural development (6). A study which was done in Singapore showed that breastfeeding is independently related to likelihood of myopia after controlling for cofactors (7). But this study had some limitations which may affect the results. This study had a small population size and its participants were from one school. All factors relating to myopia were not controlled by this study. However, data pulled from three English birth cohorts done in 10-11y and 15-16y children did not show any effect (8). Hence, results about the relationship between breastfeeding and likelihood of childhood myopia are controversial.

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 almost all cofactors which may relate to myopia; such as child's age, sex, height, birth weight, maternal age at delivery, IQ (intelligence quotient), near work, parental education and ethnicity, parental myopia, child n-3(omega-3) fatty acid and refined carbohydrate intake, maternal n-3 fatty acid intake, n-3 fatty acid intake while infancy, physical activity and other confounding factors which may have an effect on the relationship among breastfeeding pattern and myopia.

Keywords
breastfeeding, myopia, nearsightedness, children
Medical subject headings
Myopia, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01013493
Study groupRoleWhat they receive
myopicNot described
non myope-healthyNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01013493
Sponsor's protocol ID
292
Status last verified
Dec 2009
First submitted
12 Nov 2009
Last updated
2 Dec 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia and Nearsightedness, run by National Nutrition and Food Technology Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.

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