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

Primary Purpose

Malnourishment

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Omega 3
Sponsored by
Universidad Autonoma de Ciudad Juarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnourishment focused on measuring Omega-3, Cognition, Malnourishment

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Autonoma de Ciudad Juarez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega 3

Arm Description

Outcomes

Primary Outcome Measures

Cognitive development and performance
Comparation of the effects of parallels treatment

Secondary Outcome Measures

Size effect of intervention

Full Information

First Posted
September 6, 2010
Last Updated
September 9, 2010
Sponsor
Universidad Autonoma de Ciudad Juarez
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1. Study Identification

Unique Protocol Identification Number
NCT01199120
Brief Title
Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Official Title
Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de Ciudad Juarez

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnourishment
Keywords
Omega-3, Cognition, Malnourishment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega 3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3
Intervention Description
measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
Primary Outcome Measure Information:
Title
Cognitive development and performance
Description
Comparation of the effects of parallels treatment
Time Frame
three months
Secondary Outcome Measure Information:
Title
Size effect of intervention
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad Autonoma de Ciudad Juarez
City
Juarez
State/Province
Chihuahua
ZIP/Postal Code
32310
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24508294
Citation
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.
Results Reference
derived

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

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