Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208611
Status:
TERMINATED
Last Update Posted:
2014-12-18
First Post:
2005-09-13
Brief Title:
Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinsons Disease
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinsons Disease a Pilot Study
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding ended and enrollment not completed within a certain time period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Based on Parkinsons disease PDvitamin 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 Serum cobalamin B12 concentrations in patients with Parkinsons disease PD are significantly lower than B12 concentrations in a cohabiting spousal caregiver controls and b population-based age-matched controls
2 Supplementation with B12 in levodopa-treated PD patients with low 200 pgml or low-normal 200-300 pgml 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
Study Hypotheses
1 Serum cobalamin B12 concentrations in patients with Parkinsons disease PD are significantly lower than B12 concentrations in a cohabiting spousal caregiver controls and b population-based age-matched controls
2 Supplementation with B12 in levodopa-treated PD patients with low 200 pgml or low-normal 200-300 pgml 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None