Creatine on Bone Mass in Postmenopausal Women
This study is currently recruiting participants.
Verified November 2011 by University of Sao Paulo
Sponsor:
University of Sao Paulo
Collaborator:
AlzChem AG
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01472393
First received: November 8, 2011
Last updated: November 15, 2011
Last verified: November 2011
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Purpose
Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.
| Condition | Intervention |
|---|---|
|
Postmenopausal Women |
Dietary Supplement: Creatine supplementation Dietary Supplement: dextrose (placebo) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A 2-year Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women |
Resource links provided by NLM:
MedlinePlus related topics:
Bone Density
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- bone mineral density (BMD) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- bone markers [ Time Frame: 24 months ] [ Designated as safety issue: No ]will include CTX and P1NP
- history of falls [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Creatine supplementation |
Dietary Supplement: Creatine supplementation
The CR group will receive 3g of Cr monohydrate (Creapure®) per day throughout the trial. The amount will be taken as three single doses of 1 g creatine MH during the day (morning, lunch, evening). The dose of creatine will be formulated in a tablet.
|
| Placebo Comparator: Placebo |
Dietary Supplement: dextrose (placebo)
The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy postmenopausal women
- T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD
Exclusion Criteria:
- drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
- low BMI (< 18.5 Kg/m2).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472393
Contacts
| Contact: Bruno Gualano, PhD | 551130913096 | gualano@usp.br |
Locations
| Brazil | |
| University of Sao Paulo - School of Medicine | Recruiting |
| Sao Paulo, Brazil, 01246-903 | |
| Contact: Melisa Madureira, PhD 5511 30617158 melisamadureira@usp.br | |
| Principal Investigator: Bruno Gualano, PhD | |
| Principal Investigator: Rosa M' Pereira, PhD | |
Sponsors and Collaborators
University of Sao Paulo
AlzChem AG
Investigators
| Principal Investigator: | Bruno Gualano, PhD | University of Sao Paulo |
| Principal Investigator: | Rosa M Pereira, PhD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Bruno Gualano, Professor, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01472393 History of Changes |
| Other Study ID Numbers: | USP.BONE |
| Study First Received: | November 8, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
creatine supplementation bone mass postmenopausal women muscle function bone markers |
ClinicalTrials.gov processed this record on June 17, 2013