Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease

NCT00208611 | Terminated Phase 2

• 1 other identifier: IRB00045854
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Based on Parkinson's disease (PD)/vitamin B12 deficiency symptom overlap and PD patients' propensity to avoid protein (the dietary source of vitamin B12), this study proposes to prospectively investigate the vitamin B12 status of PD patients over time. In addition, this study will provide critical pilot data evaluating the efficacy of treating those patients considered to have below-normal vitamin B12 levels in serum. Further, it will also explore the concept that supplementing PD patients having "low-normal" vitamin B12 levels with vitamin B12 improves either the non-motor PD symptoms or homocysteine levels in PD patients receiving levodopa. Study Hypotheses:

1. 1.Serum cobalamin (B12) concentrations in patients with Parkinson's disease (PD) are significantly lower than B12 concentrations in a) cohabiting spousal caregiver controls; and b) population-based, age-matched controls.
2. 2.Supplementation with B12 in levodopa-treated PD patients with low (\<200 pg/ml) or low-normal (200-300 pg/ml) serum B12 levels is associated with significant improvement in their non-motor symptoms and reduces total plasma homocysteine concentration \[Hcy\], a known biomarker for risk of dementia and cerebrovascular disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Vitamin B12 concentration

  Baseline

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

Levodopa-treated Parkinson's Disease subjects with vitamin B12 \< 200 pg/ml given oral vitamin B12 supplement

Dietary Supplement: Vitamin B12 Supplementation

Interventions

Vitamin B12 Supplementation DIETARY_SUPPLEMENT

1000 micrograms daily

Also known as: vitamin B12

Open-Label Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen in Emory Healthcare System at least once between 1/1/2002 and 05/31/2006 with idiopathic Parkinson's disease (defined as):
• \>2 of cardinal signs/symptoms of Parkinson's disease (bradykinesia, tremor, rigidity)
• \>50% improvement of symptoms when dopaminergic therapy started
• Cohabiting spousal caregivers (without Parkinson's disease) of patients enrolled in study are also eligible (but not required) to participate
• Coexisting depression, if present, is stable
• Normal thyroid screen (done at Screening Visit or at Emory Healthcare System within 3 months of Screening Visit)
• Males must have normal fasting testosterone levels (done at Screening visit or within 6 months of Screening Visit)

You may not qualify if:

• Unstable medical conditions (terminal cancer, angina, etc) which could interfere with study assessments or put patient at risk for not completing the assessments.
• Dopaminergic-unresponsive parkinsonism (i.e., patient has suspected multiple systems atrophy (MSA), vascular or another form of parkinsonism)
• Untreated testosterone or thyroid abnormality

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Marian L Evatt, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)