NCT01667796

Brief Summary

This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

August 13, 2012

Results QC Date

August 25, 2015

Last Update Submit

March 1, 2019

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

Multiple sclerosisHealthy controlsPharmacokineticsVitamin D

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Serum Level of 25-hydroxyvitamin D

    Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.

    Baseline to 90 days

Secondary Outcomes (4)

  • Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)

    Baseline, 90 days

  • Gene Expression Microarray

    90 days

  • Change in Cytokine Levels

    90 days

  • Change in Percentage of B Cells

    90 days

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT
Vitamin D3

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Healthy or multiple sclerosis
  • Aged 18 to 60
  • Body mass index is between 18 kg/m2 and 30 kg/m2
  • Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
  • White race
  • Non-Hispanic ethnicity
  • Willing to use birth control during study
  • Willing to not use tanning bed during study
  • If subject has multiple sclerosis:
  • Relapsing-remitting MS, as defined by McDonald 2005 criteria
  • Screening Expanded Disability Status Scale score ≤ 3.0
  • Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab

You may not qualify if:

  • Pregnant or nursing
  • Taking multivitamin \& unwilling to remain off it during study
  • Taking cod liver oil \& unwilling to remain off it during study
  • On a fat-restricted diet
  • History of renal disease or nephrolithiasis (kidney stones)
  • History of liver disease
  • Taking thiazide diuretics
  • History of hyperthyroidism
  • History of infection with Mycobacterium species
  • History of sarcoidosis
  • History of cancer
  • History of cardiac disease
  • History of HIV
  • History of gastrointestinal disorder
  • Taking medications that interfere with gastrointestinal absorption
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Bhargava P, Fitzgerald KC, Calabresi PA, Mowry EM. Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation. JCI Insight. 2017 Oct 5;2(19):e95302. doi: 10.1172/jci.insight.95302.

    PMID: 28978801DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Limitations and Caveats

The generalizability of the findings of this study (beyond female Caucasians) has to be further tested. It is possible that there were unmeasured confounders influencing results.

Results Point of Contact

Title
Ellen Mowry
Organization
Johns Hopkins
vitamindtrialms@jhmi.edu
4106141522

Study Officials

  • Ellen M Mowry, MD, MCR

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 17, 2012

Study Start

November 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 5, 2019

Results First Posted

February 1, 2016

Record last verified: 2019-03

Locations

US(2)