Effects of Creatine Supplementation in Women With Knee Os... | NCT00749983

Studies
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

NCT00749983

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Oct 2, 2012Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis
Fibromyalgia

Interventions

Creatine supplementation
Dextrose supplementation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	creatine intake	Dietary Supplement: Creatine supplementation
2	Placebo Comparator	placebo (dextrose) intake	Dietary Supplement: Dextrose supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Creatine supplementation	Dietary Supplement		1
Dextrose supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical function	Assessed by the timed-stands test	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Strength	Assessed by the 1-repetition maximum test	12 weeks
Quality of life	health-related questionaires	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fulfill ACR criteria of knee osteoarthritis
Fulfill ACR criteria of fibromyalgia

Exclusion Criteria:

Athletes
Drugs stable for at least three months before entering the study
No limitations to resistance training

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sao Paulo School of Medicine		São Paulo	São Paulo	01246903	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003401	Creatine

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000596	Amino Acids

Browse Leaves

Not provided

Browse Branches

Not provided