Trials / Completed
CompletedNCT01199120
Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Universidad Autonoma de Ciudad Juarez · Academic / Other
- Sex
- All
- Age
- 8 Years – 12 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Omega 3 | measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2010-09-10
- Last updated
- 2010-09-10
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT01199120. Inclusion in this directory is not an endorsement.