NCT01768039

Brief Summary

Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial. They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3 multiple-sclerosis

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

January 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

January 11, 2013

Last Update Submit

January 11, 2013

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisVitamin DEDSSARR

Outcome Measures

Primary Outcomes (1)

  • Expanded disability state scale score (EDSS)

    Changes in EDSS from baseline to 6 months

Secondary Outcomes (1)

  • Annual relapse rate(ARR)

    Changes in ARR from baseline to 12 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

treatment with weekly 50000IU vitamin D

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Treatment with placebo

Drug: Placebo

Interventions

Vitamin DDRUG
Vitamin D
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI:18-30kg/m2
  • caucasian race
  • Relapsing remitting multiple sclerosis
  • treatment with interferon beta

You may not qualify if:

  • Recent vitamin D supplement therapy
  • Restricted fat diet
  • nephrolithiasis in recent 5 years
  • Past history of hyperparathyroidism, sarcoidosis, cancer
  • Past history of hepatic disease
  • Past history of gastrointestinal disease
  • Past history of mycobacterial infection
  • Past history of hypercalcemia and hypercalciuria
  • serum creatinine\>1.5
  • Smoking, drug abuse and corticosteroid therapy in recent year
  • treatment with thiazides or other drugs that inhibit vitamin D absorption
  • Disease attack in recent 2 months
  • Serum Ca\>2.6mm0l/L
  • Serum 25(OH)D\>85mmol/L
  • hypersensitivity to cholecalciferol
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazandaran University of medical sciences

Sari, Mazandaran, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Mahmoud Abedini, MD

CONTACT

01513243158mahmoudabedini@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of neurology

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 15, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

IR(1)