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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01199120
Enrollment
75
Registered
2010-09-10
Start date
2009-03-31
Completion date
2010-09-30
Last updated
2010-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnourishment

Keywords

Omega-3, Cognition, Malnourishment

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.

Interventions

DIETARY_SUPPLEMENTOmega 3

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

Sponsors

Universidad Autonoma de Ciudad Juarez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive development and performancethree monthsComparation of the effects of parallels treatment

Secondary

MeasureTime frame
Size effect of interventionthree months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026