Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
|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|
- Cognitive development and performance [ Time Frame: three months ] [ Designated as safety issue: Yes ]Comparation of the effects of parallels treatment
- Size effect of intervention [ Time Frame: three months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199120
|Universidad Autonoma de Ciudad Juarez|
|Juarez, Chihuahua, Mexico, 32310|