Back to resultsCreatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Creatine
Placebo
Vitamin D
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury
- Minimum time since injury: 3 months
Exclusion Criteria:
- Participation in resistance training programmes in the previous 6 months
- Creatine or vitamin D supplementation in the previous 6 months
Sites / Locations
- Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais
- Centro de Reabilitação do Norte
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Placebo
Creatine
Vitamin D
Arm Description
Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.
Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks.
Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks.
Outcomes
Primary Outcome Measures
Body Mass Index
Sum of 4 skinfold
Triceps, Biceps, Subscapular and Iliac crest
Corrected Arm Muscle Area
Seated Medicinal Ball Throw
Handgrip Strength with Hand Dynamometer
Manual Wheelchair Slalom Test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02099357
Brief Title
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
Official Title
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of creatine monohydrate or vitamin D supplementation on strength gains following a traditional resistance training program for adults with spinal cord injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.
Arm Title
Creatine
Arm Type
Experimental
Arm Description
Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks.
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Intervention Description
Daily supplementation with 3g of monohydrate creatine during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D supplementation with 25000 IU each two weeks during eight weeks
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
8 weeks
Title
Sum of 4 skinfold
Description
Triceps, Biceps, Subscapular and Iliac crest
Time Frame
8 weeks
Title
Corrected Arm Muscle Area
Time Frame
8 weeks
Title
Seated Medicinal Ball Throw
Time Frame
8 weeks
Title
Handgrip Strength with Hand Dynamometer
Time Frame
8 weeks
Title
Manual Wheelchair Slalom Test
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury
Minimum time since injury: 3 months
Exclusion Criteria:
Participation in resistance training programmes in the previous 6 months
Creatine or vitamin D supplementation in the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitor H Teixeira, PhD
Organizational Affiliation
Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rui Corredeira, PhD
Organizational Affiliation
Faculdade de Desporto, Universidade do Porto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Samuel Amorim, Bsc
Organizational Affiliation
Faculdade de Desporto, Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais
City
Cantanhede
State/Province
Coimbra
ZIP/Postal Code
3064-908
Country
Portugal
Facility Name
Centro de Reabilitação do Norte
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4405-565
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
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