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

This study has been completed.
Sponsor:
Information provided by:
Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier:
NCT01199120
First received: September 6, 2010
Last updated: September 9, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Malnourishment
 Dietary Supplement: Omega 3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Autonoma de Ciudad Juarez:

Primary Outcome Measures:
  • Cognitive development and performance [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    Comparation of the effects of parallels treatment


Secondary Outcome Measures:
  • Size effect of intervention [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega 3 Dietary Supplement: Omega 3
measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199120

Locations
Mexico
Universidad Autonoma de Ciudad Juarez
Juarez, Chihuahua, Mexico, 32310
Sponsors and Collaborators
Universidad Autonoma de Ciudad Juarez
  More Information

No publications provided

Responsible Party: Veronica Portillo Reyes - PI, Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier: NCT01199120     History of Changes
Other Study ID Numbers: UACJ-ICSA-VPortillo-01
Study First Received: September 6, 2010
Last Updated: September 9, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by Universidad Autonoma de Ciudad Juarez:
Omega-3
Cognition
Malnourishment

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013