NCT01803230

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 4, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 27, 2013

Last Update Submit

March 1, 2013

Conditions

Healthy

Keywords

children

Outcome Measures

Primary Outcomes (1)

  • cognitive function

    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.

    7 days

Secondary Outcomes (1)

  • tissue creatine content

    7 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo (dextrose)

Dietary Supplement: Placebo

creatine

EXPERIMENTAL

creatine supplementation

Dietary Supplement: creatine supplementation

Interventions

creatine supplementationDIETARY_SUPPLEMENT

creatine supplementation

creatine
PlaceboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • cognitive impairment
  • vegetarian diet
  • use of creatine in the past 6 months
  • chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bruno Gualano, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Merege

CONTACT

551130913096carlosmeregefilho@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 4, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 4, 2013

Record last verified: 2013-02

Locations

BR(1)