Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01199120|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : September 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Malnourishment||Dietary Supplement: Omega 3||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
|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.
- Cognitive development and performance [ Time Frame: three months ]Comparation of the effects of parallels treatment
- Size effect of intervention [ Time Frame: three months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199120
|Universidad Autonoma de Ciudad Juarez|
|Juarez, Chihuahua, Mexico, 32310|