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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 6, 2010
Last Updated Date	September 9, 2010
Start Date ^ICMJE	March 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2010)	Cognitive development and performance [ Time Frame: three months ] [ Designated as safety issue: Yes ] Comparation of the effects of parallels treatment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01199120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 9, 2010)	Size effect of intervention [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Official Title ^ICMJE	Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Malnourishment
Intervention ^ICMJE	Dietary Supplement: Omega 3 measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
Study Arm (s)	Experimental: Omega 3 Intervention: Dietary Supplement: Omega 3
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	8 Years to 12 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Mexico

Administrative Information
NCT Number ^ICMJE	NCT01199120
Other Study ID Numbers ^ICMJE	UACJ-ICSA-VPortillo-01
Has Data Monitoring Committee	No
Responsible Party	Veronica Portillo Reyes - PI, Universidad Autonoma de Ciudad Juarez
Study Sponsor ^ICMJE	Universidad Autonoma de Ciudad Juarez
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Universidad Autonoma de Ciudad Juarez
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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