ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01199120
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
Universidad Autonoma de Ciudad Juarez

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.

Condition or disease Intervention/treatment Phase
Malnourishment Dietary Supplement: Omega 3 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Study Start Date : March 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Omega 3 Dietary Supplement: Omega 3
measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.



Primary Outcome Measures :
  1. Cognitive development and performance [ Time Frame: three months ]
    Comparation of the effects of parallels treatment


Secondary Outcome Measures :
  1. Size effect of intervention [ Time Frame: three months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199120


Locations
Mexico
Universidad Autonoma de Ciudad Juarez
Juarez, Chihuahua, Mexico, 32310
Sponsors and Collaborators
Universidad Autonoma de Ciudad Juarez

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Veronica Portillo Reyes - PI, Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier: NCT01199120     History of Changes
Other Study ID Numbers: UACJ-ICSA-VPortillo-01
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by Universidad Autonoma de Ciudad Juarez:
Omega-3
Cognition
Malnourishment

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders