NCT00571285

Brief Summary

Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a role in the development of PD. In addition, low vitamin D levels have been associated with slower walking speeds, worse memory and thinking, and depression.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 24, 2017

Status Verified

April 1, 2016

Enrollment Period

3.6 years

First QC Date

December 7, 2007

Last Update Submit

January 23, 2017

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseNutritionVitamin supplementMotor functionNon-motor function

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Visit to 3 month (Treatment Visit #1) in the TUG, timed walking task (8-meters) and UPDRS III subscore

    6 months

Secondary Outcomes (1)

  • Change from Baseline Visit to 3 month (Visit #1) and 6 month (Visit #2) in the UPDRS II, BAI-II and BDI-II score.

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule once a week and 600 IU vitamin D daily for 26 weeks

Dietary Supplement: Vitamin D3Dietary Supplement: Placebo

Vitamin D

EXPERIMENTAL

50K IU vitamin D3 (high dose) weekly plus 600 IU Vitamin D3 capsule daily for 26 weeks

Dietary Supplement: Vitamin D3Dietary Supplement: Vitamin D3 - high dose

Interventions

Vitamin D3DIETARY_SUPPLEMENT

600 IU Vitamin D3 capsule daily

Also known as: Cholecalciferol
PlaceboVitamin D
Vitamin D3 - high doseDIETARY_SUPPLEMENT

50,000 IU Vitamin D3 capsule once a week

Also known as: Cholecalciferol
Vitamin D
PlaceboDIETARY_SUPPLEMENT

Placebo capsule given once a week

Placebo

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants must be able to provide informed consent or have a legal representative (defined by Georgia Law) who can give consent.
  • Diagnosis of IPD, based on history of 2/3 cardinal features of PD (tremor, bradykinesia and rigidity) and definite response to dopaminergic therapy.
  • Previous serum 25-OH vitamin D concentration measured by treating physician within previous 3 months.
  • Eligible participants must be able to complete the study questionnaires and assessments (e.g., participant must be judged able to complete TUG at screening/baseline).
  • Participants must be free of active cancer or other serious medical condition which might reasonably preclude their completing the 6-month intervention.
  • Participants must be able to complete an 8 meter walk at screening evaluation.

You may not qualify if:

  • Patients with PD, H\&Y stage I-IV will be eligible to participate in this study.
  • Participants must be ages 18-89 years.
  • Patient with a history of hypercalcemia, hypercalciuria, liver failure, end-stage renal disease (National Kidney Foundation Classification Stage 5) or kidney stones within the past 5 years will be excluded.
  • Specifically, potential participants with GFR (estimated or measured) \<15 ml/min are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Marian L Evatt, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

June 1, 2007

Primary Completion

January 1, 2011

Study Completion

September 1, 2015

Last Updated

January 24, 2017

Record last verified: 2016-04

Locations

US(1)