NCT02267005

Brief Summary

This project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (CR) supplementation on muscle function and muscle metabolism in children with Dermatomyositis (DM). The investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in DM. Improvements in muscle function and fatigue through CR use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with DM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

October 1, 2014

Last Update Submit

May 10, 2018

Conditions

Juvenile Dermatomyositis

Outcome Measures

Primary Outcomes (1)

  • Muscle function

    Will be determined by mean power output using a Wingate cycle ergometer protocol

    6 months

Secondary Outcomes (6)

  • Muscle metabolism

    6 months

  • Quality of life

    6 months

  • Disease Activity

    6 months

  • Muscle Strength

    6 months

  • Fatigue

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

patients on this arm will be treated with creapure supplements

Dietary Supplement: Creapure

Placebo

PLACEBO COMPARATOR

patients on this arm will be given a placebo glucose tablet supplement

Dietary Supplement: Glucose Tablet

Interventions

CreapureDIETARY_SUPPLEMENT

Patients will be prescribed a creapure supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.

Also known as: ultrapure creatine monohydrate
Treatment
Glucose TabletDIETARY_SUPPLEMENT

Patients will be prescribed the placebo supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.

Also known as: Placebo
Placebo

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 7 to 18 years
  • Diagnosis of probable JDM (onset \<16 years) according to Bohan and Peter criteria
  • Subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician)
  • Minimum height of 132.5cm

You may not qualify if:

  • Subjects newly diagnosed with JDM within the previous 6 months
  • Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
  • Subjects with impaired kidney function as determined from baseline visit screening lab values
  • Subjects who are currently pregnant or planning to become pregnant within the study period
  • Subjects who are shorter than 132.5cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

Glucose

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Rheumatology / Sr Scientist

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 17, 2014

Study Start

March 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

CA(1)