Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedSeptember 10, 2010
September 1, 2010
1.5 years
September 6, 2010
September 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive development and performance
Comparation of the effects of parallels treatment
three months
Secondary Outcomes (1)
Size effect of intervention
three months
Study Arms (1)
Omega 3
EXPERIMENTALInterventions
measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
Eligibility Criteria
You may qualify if:
- Children aged 8- 12 years that attending the selected elementary schools.
- Whit no problems for swallowing pills.
- Willing to participate in the study and perform all measurements including anthropometry and cognitive evaluation
- Informed consent signed by parent or caregiver.
- Parents intend to stay in the study for three months.
You may not qualify if:
- Neurological and/or hormonal illnesses.
- Children using medication which interferes with study measurements.
- Omega-3 or any other vitamin supplements consumption within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Autonoma de Ciudad Juarez
Juárez, Chihuahua, 32310, Mexico
Related Publications (1)
Portillo-Reyes V, Perez-Garcia M, Loya-Mendez Y, Puente AE. Clinical significance of neuropsychological improvement after supplementation with omega-3 in 8-12 years old malnourished Mexican children: a randomized, double-blind, placebo and treatment clinical trial. Res Dev Disabil. 2014 Apr;35(4):861-70. doi: 10.1016/j.ridd.2014.01.013. Epub 2014 Feb 6.
PMID: 24508294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2010
First Posted
September 10, 2010
Study Start
March 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
September 10, 2010
Record last verified: 2010-09