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

This study has been completed.
Sponsor:
Information provided by:
Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier:
NCT01199120
First received: September 6, 2010
Last updated: September 9, 2010
Last verified: September 2010

September 6, 2010
September 9, 2010
March 2009
September 2010   (final data collection date for primary outcome measure)
Cognitive development and performance [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Comparation of the effects of parallels treatment
Same as current
Complete list of historical versions of study NCT01199120 on ClinicalTrials.gov Archive Site
Size effect of intervention [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Malnourishment
Dietary Supplement: Omega 3
measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
Experimental: Omega 3
Intervention: Dietary Supplement: Omega 3
Portillo-Reyes V, Pérez-García M, Loya-Méndez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01199120
UACJ-ICSA-VPortillo-01
No
Veronica Portillo Reyes - PI, Universidad Autonoma de Ciudad Juarez
Universidad Autonoma de Ciudad Juarez
Not Provided
Not Provided
Universidad Autonoma de Ciudad Juarez
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP