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CompletedNCT02099357Updated Aug 4, 2015

Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training

An interventional study of Creatine and Placebo in Spinal Cord Injuries, sponsored by Universidade do Porto. Completed at 2 sites in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-04.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Cord Injuries
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 14 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Spinal cord injury
  • Minimum time since injury: 3 months

Exclusion criteria

Exclusion Criteria:

  • Participation in resistance training programmes in the previous 6 months
  • Creatine or vitamin D supplementation in the previous 6 months
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks.

    Dietary Supplement: Placebo

  • Experimental
    Creatine

    Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks.

    Dietary Supplement: Creatine

  • Active comparator
    Vitamin D

    Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks.

    Dietary Supplement: Vitamin D

Interventions

  • Dietary supplementCreatine

    Daily supplementation with 3g of monohydrate creatine during 8 weeks

  • Dietary supplementPlacebo
  • Dietary supplementVitamin D

    Vitamin D supplementation with 25000 IU each two weeks during eight weeks

06

What researchers measure

Primary outcomes

  1. Body Mass Index

    Time frame: 8 weeks

  2. Sum of 4 skinfold

    Triceps, Biceps, Subscapular and Iliac crest

    Time frame: 8 weeks

  3. Corrected Arm Muscle Area

    Time frame: 8 weeks

  4. Seated Medicinal Ball Throw

    Time frame: 8 weeks

  5. Handgrip Strength with Hand Dynamometer

    Time frame: 8 weeks

  6. Manual Wheelchair Slalom Test

    Time frame: 8 weeks

07

Study locations

2 sites
  • Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais
    Cantanhede, Coimbra 3064-908, Portugal
  • Centro de Reabilitação do Norte
    Vila Nova de Gaia, Porto 4405-565, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02099357
Lead sponsor
Universidade do Porto
Responsible party
Samuel Amorim (Bsc, Universidade do Porto) — Principal investigator
First posted
Mar 28, 2014
Start date
Sep 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 4, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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