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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099357
• Other study ID #: FADEUPAFA20132015
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: August 1, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Faculdade de Desporto da Universidade do Porto
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Dietary Supplement:
• Creatine
Daily supplementation with 3g of monohydrate creatine during 8 weeks
• Placebo

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

Locations

Country	Name	City	State
Portugal	Centro de Medicina de Reabilitação da Região Centro - Rovisco Pais	Cantanhede	Coimbra
Portugal	Centro de Reabilitação do Norte	Vila Nova de Gaia	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		8 weeks	Yes
Primary	Sum of 4 skinfold	Triceps, Biceps, Subscapular and Iliac crest	8 weeks	Yes
Primary	Corrected Arm Muscle Area		8 weeks	Yes
Primary	Seated Medicinal Ball Throw		8 weeks	Yes
Primary	Handgrip Strength with Hand Dynamometer		8 weeks	Yes
Primary	Manual Wheelchair Slalom Test		8 weeks	Yes