Clinical trial NCT01199120: Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Official title: Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malnourishment
Keywords: Omega-3
Cognition
Malnourishment
Lead sponsor: Universidad Autonoma de Ciudad Juarez
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive development and performance
timeFrame: three months
Secondary outcomes:
measure: Size effect of intervention
timeFrame: three months
Other outcomes:
Locations:
city: Juarez
country: Mexico
facility: Universidad Autonoma de Ciudad Juarez
state: Chihuahua
Study officials:
References:
citation: 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.