NCT01238926

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

2.5 years

First QC Date

November 9, 2010

Last Update Submit

November 10, 2010

Conditions

Parkinson's Disease

Keywords

Oxidative stressParkinson's diseaseHomocysteineGlutathioneB vitamins

Outcome Measures

Primary Outcomes (10)

  • Plasma homocysteine

    6 weeks

  • Plasma glutathione (GSH)

    6 weeks

  • Plasma glutathione disulfide (GSSG)

    6 weeks

  • GSH:GSSG ratio

    6 weeks

  • Plasma vitamin B6

    6 weeks

  • Plasma vitamin B12

    6 weeks

  • Plasma folate

    6 weeks

  • Balance

    6 weeks

  • Strength

    6 weeks

  • Kinematic gait analysis

    6 weeks

Study Arms (4)

PD vitamin supplementation

EXPERIMENTAL
Dietary Supplement: PD vitamin supplementation

PD exercise intervention

EXPERIMENTAL
Other: PD exercise intervention

PD vitamin + exercise

EXPERIMENTAL
Other: PD vitamin + exercise

PD control

NO INTERVENTION

Interventions

PD vitamin supplementationDIETARY_SUPPLEMENT

25 mg/day of Vitamin B6 2,000 mcg/day of Vitamin B12 5 mg/day of Folic Acid

Also known as: Source Naturals® Vitamin B6 25 mg, Source Naturals® Vitamin B12 2000 mcg, Source Naturals® Folic Acid 1000 mcg
PD vitamin supplementation
PD exercise interventionOTHER

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.

Also known as: CYBEX(R)
PD exercise intervention
PD vitamin + exerciseOTHER

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.

Also known as: Source Naturals® Vitamin B6 25 mg, Source Naturals® Vitamin B12 2000 mcg, Source Naturals® Folic Acid 1000 mcg, CYBEX(R)
PD vitamin + exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • A neurological condition other than PD/
  • Anyone who is currently taking any vitamin supplementation.
  • Smokers.
  • Anyone currently engaged in weight training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, 11568-8000, United States

Location

Related Publications (10)

  • Bronte-Stewart HM, Minn AY, Rodrigues K, Buckley EL, Nashner LM. Postural instability in idiopathic Parkinson's disease: the role of medication and unilateral pallidotomy. Brain. 2002 Sep;125(Pt 9):2100-14. doi: 10.1093/brain/awf207.

    PMID: 12183355BACKGROUND

  • Elokda AS, Nielsen DH. Effects of exercise training on the glutathione antioxidant system. Eur J Cardiovasc Prev Rehabil. 2007 Oct;14(5):630-7. doi: 10.1097/HJR.0b013e32828622d7.

    PMID: 17925621BACKGROUND

  • Malouf R, Grimley Evans J. The effect of vitamin B6 on cognition. Cochrane Database Syst Rev. 2003;(4):CD004393. doi: 10.1002/14651858.CD004393.

    PMID: 14584010BACKGROUND

  • Miller JW, Selhub J, Nadeau MR, Thomas CA, Feldman RG, Wolf PA. Effect of L-dopa on plasma homocysteine in PD patients: relationship to B-vitamin status. Neurology. 2003 Apr 8;60(7):1125-9. doi: 10.1212/01.wnl.0000055899.24594.8e.

    PMID: 12682318BACKGROUND

  • Morris MS. Homocysteine and Alzheimer's disease. Lancet Neurol. 2003 Jul;2(7):425-8. doi: 10.1016/s1474-4422(03)00438-1.

    PMID: 12849121BACKGROUND

  • Mosharov E, Cranford MR, Banerjee R. The quantitatively important relationship between homocysteine metabolism and glutathione synthesis by the transsulfuration pathway and its regulation by redox changes. Biochemistry. 2000 Oct 24;39(42):13005-11. doi: 10.1021/bi001088w.

    PMID: 11041866BACKGROUND

  • Postuma RB, Lang AE. Homocysteine and levodopa: should Parkinson disease patients receive preventative therapy? Neurology. 2004 Sep 14;63(5):886-91. doi: 10.1212/01.wnl.0000137886.74175.5a.

    PMID: 15365141BACKGROUND

  • Viguie CA, Frei B, Shigenaga MK, Ames BN, Packer L, Brooks GA. Antioxidant status and indexes of oxidative stress during consecutive days of exercise. J Appl Physiol (1985). 1993 Aug;75(2):566-72. doi: 10.1152/jappl.1993.75.2.566.

    PMID: 7693646BACKGROUND

  • Vincent HK, Bourguignon C, Vincent KR. Resistance training lowers exercise-induced oxidative stress and homocysteine levels in overweight and obese older adults. Obesity (Silver Spring). 2006 Nov;14(11):1921-30. doi: 10.1038/oby.2006.224.

    PMID: 17135607BACKGROUND

  • Zoccolella S, Lamberti P, Armenise E, de Mari M, Lamberti SV, Mastronardi R, Fraddosio A, Iliceto G, Livrea P. Plasma homocysteine levels in Parkinson's disease: role of antiparkinsonian medications. Parkinsonism Relat Disord. 2005 Mar;11(2):131-3. doi: 10.1016/j.parkreldis.2004.07.008. Epub 2004 Dec 20.

    PMID: 15734674BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Study Start

May 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

US(1)