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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by New York Institute of Technology.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stony Brook University
Information provided by:
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT01238926
First received: November 9, 2010
Last updated: November 10, 2010
Last verified: November 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Plasma homocysteine [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma glutathione (GSH) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma glutathione disulfide (GSSG) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • GSH:GSSG ratio [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma vitamin B6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma vitamin B12 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma folate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Strength [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Kinematic gait analysis [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Morris MS. Homocysteine and alzheimer's disease. Lancet Neurol [Internet]. 2003 Jul;2(7):425-8.

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
Study First Received: November 9, 2010
Last Updated: November 10, 2010
Health Authority: United States: Institutional Review Board

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
Folic Acid
Vitamin B Complex
Vitamin B 12
Hydroxocobalamin
 Vitamin B 6
Pyridoxine
Pyridoxal
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013