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

Malnourishment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199120
• Other study ID #: UACJ-ICSA-VPortillo-01
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2010
• Last updated: September 9, 2010
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Universidad Autonoma de Ciudad Juarez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnourishment
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Ciudad Juarez	Juarez	Chihuahua

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Ciudad Juarez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive development and performance	Comparation of the effects of parallels treatment	three months	Yes
Secondary	Size effect of intervention		three months	Yes