NCT01472393

Brief Summary

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.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

6.1 years

First QC Date

November 8, 2011

Last Update Submit

January 29, 2015

Conditions

Postmenopausal Women

Keywords

creatine supplementationbone masspostmenopausal womenmuscle functionbone markers

Outcome Measures

Primary Outcomes (1)

  • bone mineral density (BMD)

    12 and 24 months

Secondary Outcomes (6)

  • bone markers

    12 and 24 months

  • history of falls

    24 months

  • bone microarchitecture

    12 and 24 months

  • muscle function

    12 and 24 months

  • lean mass

    12 and 24 months

  • +1 more secondary outcomes

Study Arms (2)

Creatine supplementation

EXPERIMENTAL
Dietary Supplement: Creatine supplementation

Placebo

PLACEBO COMPARATOR
Dietary Supplement: dextrose (placebo)

Interventions

Creatine supplementationDIETARY_SUPPLEMENT

The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.

Creatine supplementation
dextrose (placebo)DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy postmenopausal women
  • T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo - School of Medicine

São Paulo, São Paulo, 01246-903, Brazil

RECRUITING

Related Publications (3)

  • Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.

    PMID: 31257405DERIVED

  • Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17.

    PMID: 26192975DERIVED

  • Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.

    PMID: 24530883DERIVED

MeSH Terms

Interventions

CreatineGlucose

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Rosa M Pereira, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Gualano, PhD

CONTACT

551130913096gualano@usp.br

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

November 8, 2011

First Posted

November 16, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

BR(1)