CClinicalTrials.gg
Sign In
CompletedNCT01024777Updated Feb 6, 2013

Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

A Phase 1 interventional study of Cholecalciferol and Cholecalciferol in Multiple Sclerosis and Vitamin D Deficiency, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-02-06.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
  • Vitamin D Deficiency

Keywords

  • cholecalciferol
  • multiple sclerosis
  • vitamin D
  • D3
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    High dose cholecalciferol

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

    Drug: Cholecalciferol

  • Active comparator
    Low dose cholecalciferol

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

    Drug: Cholecalciferol

Interventions

  • DrugCholecalciferol

    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

  • DrugCholecalciferol

    Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)

    Also known as: Vitamin D3

06

What researchers measure

Primary outcomes

  1. Assess safety of high dose cholecalciferol in patients with multiple sclerosis

    Time frame: 3-6 months

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

    Time frame: 3-6 months

Secondary outcomes

  1. Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis

    Time frame: 6 months

07

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01024777
Lead sponsor
Johns Hopkins University
Responsible party
Peter A. Calabresi (Professor of Neurology, Johns Hopkins University) — Principal investigator
First posted
Dec 3, 2009
Start date
Mar 2010
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 6, 2013

Study contacts

Peter Calabresi, MD
principal investigator · Johns Hopkins University
John Ratchford, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Multiple Sclerosis→

Other studies from this sponsor

Johns Hopkins University

Start the discussion