NCT01024777

Brief Summary

The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Mar 2010

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

December 2, 2009

Last Update Submit

February 5, 2013

Conditions

Multiple SclerosisVitamin D Deficiency

Keywords

cholecalciferolmultiple sclerosisvitamin DD3

Outcome Measures

Primary Outcomes (2)

  • Assess safety of high dose cholecalciferol in patients with multiple sclerosis

    3-6 months

  • Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis

    3-6 months

Secondary Outcomes (1)

  • Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis

    6 months

Study Arms (2)

High dose cholecalciferol

ACTIVE COMPARATOR

Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.

Drug: Cholecalciferol

Low dose cholecalciferol

ACTIVE COMPARATOR

Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)

Also known as: Vitamin D3
High dose cholecalciferol

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between ages of 18-55 years (inclusive)
  • Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
  • Patients with or without immunomodulatory therapy for RRMS
  • Diagnosis of multiple sclerosis

You may not qualify if:

  • Serum 25(OH) vitamin D deficient level \< 20 ng/mL
  • High dose vitamin D supplementation in the past 3 months
  • Pregnancy
  • History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
  • Baseline serum creatinine above 1.5
  • Hypersensitivity to vitamin D preparations
  • Milk allergy
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple SclerosisVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Peter Calabresi, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • John Ratchford, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

March 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

US(1)