- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02099357
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
August 1, 2015 updated by: Samuel Amorim, Universidade do Porto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Coimbra
-
Cantanhede, Coimbra, Portugal, 3064-908
- Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais
-
-
Porto
-
Vila Nova de Gaia, Porto, Portugal, 4405-565
- Centro de Reabilitação do Norte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.
|
|
Experimental: Creatine
Daily supplementation with 3g of monohydrate creatine during eight weeks.
Placebo ampoules each two weeks.
|
Daily supplementation with 3g of monohydrate creatine during 8 weeks
|
Active Comparator: Vitamin D
Daily supplementation with 3g of dextrose during eight weeks.
Vitamin D supplementation, 25000 IU each two weeks.
|
Vitamin D supplementation with 25000 IU each two weeks during eight weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 8 weeks
|
8 weeks
|
|
Sum of 4 skinfold
Time Frame: 8 weeks
|
Triceps, Biceps, Subscapular and Iliac crest
|
8 weeks
|
Corrected Arm Muscle Area
Time Frame: 8 weeks
|
8 weeks
|
|
Seated Medicinal Ball Throw
Time Frame: 8 weeks
|
8 weeks
|
|
Handgrip Strength with Hand Dynamometer
Time Frame: 8 weeks
|
8 weeks
|
|
Manual Wheelchair Slalom Test
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Vitor H Teixeira, PhD, Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto
- Study Chair: Rui Corredeira, PhD, Faculdade de Desporto, Universidade do Porto
- Principal Investigator: Samuel Amorim, Bsc, Faculdade de Desporto, Universidade do Porto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 21, 2014
First Submitted That Met QC Criteria
March 27, 2014
First Posted (Estimate)
March 28, 2014
Study Record Updates
Last Update Posted (Estimate)
August 4, 2015
Last Update Submitted That Met QC Criteria
August 1, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FADEUPAFA20132015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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