NCT02099357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

March 21, 2014

Last Update Submit

August 1, 2015

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

  • Body Mass Index

    8 weeks

  • Sum of 4 skinfold

    Triceps, Biceps, Subscapular and Iliac crest

    8 weeks

  • Corrected Arm Muscle Area

    8 weeks

  • Seated Medicinal Ball Throw

    8 weeks

  • Handgrip Strength with Hand Dynamometer

    8 weeks

  • Manual Wheelchair Slalom Test

    8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Creatine

EXPERIMENTAL

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

Dietary Supplement: Creatine

Vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D

Interventions

CreatineDIETARY_SUPPLEMENT

Daily supplementation with 3g of monohydrate creatine during 8 weeks

Creatine
PlaceboDIETARY_SUPPLEMENT
Placebo
Vitamin DDIETARY_SUPPLEMENT

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

Vitamin D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais

Cantanhede, Coimbra District, 3064-908, Portugal

Location

Centro de Reabilitação do Norte

Vila Nova de Gaia, Porto District, 4405-565, Portugal

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

CreatineVitamin D

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vitor H Teixeira, PhD

    Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto

    STUDY DIRECTOR

  • Rui Corredeira, PhD

    Faculdade de Desporto, Universidade do Porto

    STUDY CHAIR

  • Samuel Amorim, Bsc

    Faculdade de Desporto, Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bsc

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 28, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

PT(2)