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Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition

NCT ID: NCT01199120

Last Updated: 2010-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-09-30

Brief Summary

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Adequate nutrition is one of the critical biological processes to learning and cognitive development of children. And is understandable that malnourishment affect these processes. Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in cognitive development and academic performance. However, studies have been limited. Therefore is of interest to know the effects that has supplement with Omega-3 for children 8-12 years with malnutrition in a randomized, blind, placebo-controlled.

Detailed Description

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Adequate nutrition is one of the most critical biological processes to learning and cognitive development of children, and malnourishment is understandable these processes are affected. Moreover, in recent decades is has been investigated the beneficial effects of Omega-3 in cognitive development and academic performance. However, studies have been limited. The present study will investigate the efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.

The study will follow a randomized, double-blind, placebo-controlled design in which children aged 6-12 years will followed for a period of three months to assess cognitive development, academic performance and nutritional status . Intervention will take place in elementary schools, where children will receive two intervention products daily and one more in their houses. The products will contain omega-3 fatty acids, placebo, or only neuropsychological evaluation (control group with normal nutrition children). At baseline, and 3months cognitive tests will be administered and assess nutritional status. Compliance will be measured weekly.

We hypothesize that after 12 months of intervention, children consuming omega-3 fatty acids will have statistically significant higher improvement in scores on cognitive tests, than placebo and normal nutrition children.

Conditions

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Malnourishment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Omega 3

Group Type EXPERIMENTAL

Omega 3

Intervention Type DIETARY_SUPPLEMENT

measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.

Interventions

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Omega 3

measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Children aged 8- 12 years that attending the selected elementary schools.
2. Whit no problems for swallowing pills.
3. Willing to participate in the study and perform all measurements including anthropometry and cognitive evaluation
4. Informed consent signed by parent or caregiver.
5. Parents intend to stay in the study for three months.

Exclusion Criteria

1. Neurological and/or hormonal illnesses.
2. Children using medication which interferes with study measurements.
3. Omega-3 or any other vitamin supplements consumption within the last 6 months.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Ciudad Juarez

OTHER

Sponsor Role lead

Responsible Party

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Universidad Autonoma de Ciudad Juarez

Locations

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Universidad Autonoma de Ciudad Juarez

Juárez, Chihuahua, Mexico

Site Status

Countries

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Mexico

References

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Portillo-Reyes V, Perez-Garcia M, Loya-Mendez Y, Puente AE. Clinical significance of neuropsychological improvement after supplementation with omega-3 in 8-12 years old malnourished Mexican children: a randomized, double-blind, placebo and treatment clinical trial. Res Dev Disabil. 2014 Apr;35(4):861-70. doi: 10.1016/j.ridd.2014.01.013. Epub 2014 Feb 6.

Reference Type DERIVED
PMID: 24508294 (View on PubMed)

Other Identifiers

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UACJ-ICSA-VPortillo-01

Identifier Type: -

Identifier Source: org_study_id