Spinal Cord InjuriesNCT02099357
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
A study testing Creatine and Vitamin D in people with Spinal Cord Injuries, run by Universidade do Porto at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Creatine and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesPortugal
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spinal cord injury
- Minimum time since injury: 3 months
Who cannot join
- Participation in resistance training programmes in the previous 6 months
- Creatine or vitamin D supplementation in the previous 6 months
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais
Cantanhede, Coimbra District, 3064-908
Centro de Reabilitação do Norte
Vila Nova de Gaia, Porto District, 4405-565
About this study
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Creatine, Placebo, Vitamin D
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Daily supplementation with 3g of monohydrate creatine during 8 weeks
PlaceboDietary supplement
Vitamin DDietary supplement
Vitamin D supplementation with 25000 IU each two weeks during eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks. Receives: Dietary Supplement: Placebo |
| Creatine | Experimental | Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks. Receives: Dietary Supplement: Creatine |
| Vitamin D | Active comparator | Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 8 weeks
Sum of 4 skinfold
Triceps, Biceps, Subscapular and Iliac crest
Measured: 8 weeks
Corrected Arm Muscle Area
Measured: 8 weeks
Seated Medicinal Ball Throw
Measured: 8 weeks
Handgrip Strength with Hand Dynamometer
Measured: 8 weeks
Manual Wheelchair Slalom Test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Amorim, Universidade do Porto
- Investigators
- Vitor H Teixeira, PhD, Study director, Faculdade de Ciências da Nutrição e Alimentação, Universidade do PortoRui Corredeira, PhD, Study chair, Faculdade de Desporto, Universidade do PortoSamuel Amorim, Bsc, Principal investigator, Faculdade de Desporto, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099357
- Sponsor's protocol ID
- FADEUPAFA20132015
- Status last verified
- Aug 2015
- First submitted
- 21 Mar 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training
- ClinicalTrials.gov ID
- NCT02099357
- Acronym / sponsor ID
- FADEUPAFA20132015
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks. |
| Creatine | Experimental | Dietary Supplement: CreatineDaily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks. |
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DDaily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spinal cord injury
- Minimum time since injury: 3 months
Key exclusion criteria (2 listed)
- Participation in resistance training programmes in the previous 6 months
- Creatine or vitamin D supplementation in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineDaily supplementation with 3g of monohydrate creatine during 8 weeks | Dietary supplement | Creatine |
| Placebo | Dietary supplement | Placebo |
| Vitamin DVitamin D supplementation with 25000 IU each two weeks during eight weeks | Dietary supplement | Vitamin D |
Primary outcome
Body Mass Index
Time frame: 8 weeks
Sum of 4 skinfold
Time frame: 8 weeks
Triceps, Biceps, Subscapular and Iliac crest
Corrected Arm Muscle Area
Time frame: 8 weeks
Seated Medicinal Ball Throw
Time frame: 8 weeks
Handgrip Strength with Hand Dynamometer
Time frame: 8 weeks
Manual Wheelchair Slalom Test
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor H Teixeira, PhD study director
Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto
Rui Corredeira, PhD study chair
Faculdade de Desporto, Universidade do Porto
Samuel Amorim, Bsc principal investigator
Faculdade de Desporto, Universidade do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine and Vitamin D in people with Spinal Cord Injuries, run by Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.