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Creatine Supplementation on Cognition in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803230
First Posted: March 4, 2013
Last Update Posted: March 4, 2013
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.
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
  Purpose
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.

Condition Intervention
Healthy Dietary Supplement: creatine supplementation Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Creatine Supplementation on Cognitive Function in Children

Resource links provided by NLM:


Further study details as provided by Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • cognitive function [ Time Frame: 7 days ]
    assessed by a battery of cognitive tests as follows: colors and words attention test, controlled words association test, memory and figures learning, mental flexibility test and inhibitory control, digit span test, and intelligence quotient.


Secondary Outcome Measures:
  • tissue creatine content [ Time Frame: 7 days ]
    as assessed by 1H-MRS.


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo (dextrose)
Dietary Supplement: Placebo
Experimental: creatine
creatine supplementation
Dietary Supplement: creatine supplementation
creatine supplementation

  Eligibility

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:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy children
  • age between 10 to 12 years of age

Exclusion Criteria:

  • cognitive impairment
  • vegetarian diet
  • use of creatine in the past 6 months
  • chronic kidney disease
  Contacts and Locations
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): NCT01803230


Contacts
Contact: Carlos Merege 551130913096 carlosmeregefilho@gmail.com

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Carlos Merege    5511 30913096    carlosmeregefilho@gmail.com   
Principal Investigator: Bruno Gualano, Professor         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruno Gualano, Professor University of Sao Paulo
  More Information

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01803230     History of Changes
Other Study ID Numbers: Creatine in Children
First Submitted: February 27, 2013
First Posted: March 4, 2013
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by Bruno Gualano, University of Sao Paulo:
children