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

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.

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

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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