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

Phase 2

Completed

• Conditions: Malnourishment
• Interventions: Dietary Supplement: Omega 3

• Registration Number: NCT01199120
• Lead Sponsor: Universidad Autonoma de Ciudad Juarez

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.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-09
• Last Update Submitted: 2010-09-09
• Study First Posted: 2010-09-10
• Last Update Posted: 2010-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega 3	Omega 3	-

Primary Outcome Measures

Name	Time	Method
Cognitive development and performance	three months	Comparation of the effects of parallels treatment

Secondary Outcome Measures

Name	Time	Method
Size effect of intervention	three months

Trial Locations

Locations (1)

Universidad Autonoma de Ciudad Juarez; 🇲🇽 Juarez, Chihuahua, Mexico