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Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by New York Institute of Technology.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238926
First Posted: November 11, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stony Brook University
Information provided by:
New York Institute of Technology
  Purpose
This experiment seeks to determine whether individuals with PD will benefit from vitamin B6 (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether they will benefit from a 6-week circuit training program, or whether they will benefit from a combination of the two interventions. The outcome variables will include: plasma homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities, kinematic gait analysis, and a quality of life questionnaire.

Condition Intervention
Parkinson's Disease Dietary Supplement: PD vitamin supplementation Other: PD exercise intervention Other: PD vitamin + exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by New York Institute of Technology:

Primary Outcome Measures:
  • Plasma homocysteine [ Time Frame: 6 weeks ]
  • Plasma glutathione (GSH) [ Time Frame: 6 weeks ]
  • Plasma glutathione disulfide (GSSG) [ Time Frame: 6 weeks ]
  • GSH:GSSG ratio [ Time Frame: 6 weeks ]
  • Plasma vitamin B6 [ Time Frame: 6 weeks ]
  • Plasma vitamin B12 [ Time Frame: 6 weeks ]
  • Plasma folate [ Time Frame: 6 weeks ]
  • Balance [ Time Frame: 6 weeks ]
  • Strength [ Time Frame: 6 weeks ]
  • Kinematic gait analysis [ Time Frame: 6 weeks ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD vitamin supplementation Dietary Supplement: PD vitamin supplementation
25 mg/day of Vitamin B6 2,000 mcg/day of Vitamin B12 5 mg/day of Folic Acid
Other Names:
  • Source Naturals® Vitamin B6 25 mg
  • Source Naturals® Vitamin B12 2000 mcg
  • Source Naturals® Folic Acid 1000 mcg
Experimental: PD exercise intervention Other: PD exercise intervention
Cardiovascular training (treadmill and StairMaster), 20 min; and strength training (2 sets of 15 repetitions of 60-70% of 1 repetition maximum [RM]) using machines that provide the following motions: knee extension, knee flexion, leg press, elbow flexion, elbow extension, seated dip.
Other Name: CYBEX(R)
Experimental: PD vitamin + exercise Other: PD vitamin + exercise
25 mg/day of Vitamin B6 2,000 mcg/day of Vitamin B12 5 mg/day of Folic Acid Cardiovascular training (treadmill and StairMaster), 20 min; and strength training (2 sets of 15 repetitions of 60-70% of 1 repetition maximum [RM]) using machines that provide the following motions: knee extension, knee flexion, leg press, elbow flexion, elbow extension, seated dip.
Other Names:
  • Source Naturals® Vitamin B6 25 mg
  • Source Naturals® Vitamin B12 2000 mcg
  • Source Naturals® Folic Acid 1000 mcg
  • CYBEX(R)
No Intervention: PD control

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical clearance to perform an exercise tolerance test and training program.
  • A diagnosis of PD at stage 2 on the Hoehn and Yahr scale.

Exclusion Criteria:

  • A neurological condition other than PD/
  • Anyone who is currently taking any vitamin supplementation.
  • Smokers.
  • Anyone currently engaged in weight training.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238926


Locations
United States, New York
New York Institute of Technology, New York College of Osteopathic Medicine, Academic Health Care Center, Adele Smithers Parkinson's Disease Treatment Center
Old Westbury, New York, United States, 11568-8000
Sponsors and Collaborators
New York Institute of Technology
Stony Brook University
Investigators
Principal Investigator: William G Werner, PT, EdD New York Institute of Technology, New York College of Osteopathic Medicine
Principal Investigator: Joanne Donoghue, PhD New York Institute of Technology, New York College of Osteopathic Medicine
  More Information

Publications:

Responsible Party: William Werner, PT, EdD, New York Institute of Technology, New York College of Osteopathic Medicine, Academic Health Care Center
ClinicalTrials.gov Identifier: NCT01238926     History of Changes
Other Study ID Numbers: BHS-545
First Submitted: November 9, 2010
First Posted: November 11, 2010
Last Update Posted: October 12, 2017
Last Verified: November 2010

Keywords provided by New York Institute of Technology:
Oxidative stress
Parkinson's disease
Homocysteine
Glutathione
B vitamins

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics