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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01817673
Other study ID # Creatine & kidney
Secondary ID
Status Completed
Phase N/A
First received March 20, 2013
Last updated March 22, 2013
Start date July 2011
Est. completion date February 2013

Study information

Verified date March 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet. The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- participation in recreational resistance training

- consumption of a high-protein diet (= 1.2 g/Kg/d)

Exclusion Criteria:

- vegetarian diet

- use of creatine supplements in the past 6 months

- chronic kidney disease

- use of anabolic steroids.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
creatine
20 g/d for 5 d followed by 5 g/d throughout the trial
placebo


Locations

Country Name City State
Brazil Univsersity of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary kidney function as assessed by 51Cr-EDTA clearance 3 months Yes
Secondary proteinuria 3 months Yes
Secondary albuminuria 3 months Yes
Secondary serum urea 3 months Yes
Secondary serum creatinine 3 months Yes
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