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Creatine Supplementation on Cognition in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01803230
First received: February 27, 2013
Last updated: March 1, 2013
Last verified: February 2013
  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: Double Blind (Subject, Caregiver, 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 University of Sao Paulo:

Primary Outcome Measures:
  • cognitive function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01803230     History of Changes
Other Study ID Numbers: Creatine in Children
Study First Received: February 27, 2013
Last Updated: March 1, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
children

ClinicalTrials.gov processed this record on November 24, 2014