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Completed

NCT Number: NCT01199120

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidad Autonoma de Ciudad Juarez

Juárez, Chihuahua, 32310, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Omega 3

Dietary Supplement

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

Primary outcomes

  1. Cognitive development and performance

    Time frame: three months

    Comparation of the effects of parallels treatment

Secondary outcomes

  1. Size effect of intervention

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Ciudad Juarez

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Sep 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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