Vitamine D in Multiple Sclerosis | NCT01768039

Studies
Vitamine D in Multiple Sclerosis

NCT01768039

Sponsor

Mazandaran University of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 15, 2013Estimated

Enrollment

240Estimated

Phase

Phase 3

Conditions

Multiple Sclerosis

Interventions

Vitamin D
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Jan 11, 2013

First Submission Date that Met QC Criteria

Jan 11, 2013

First Posted Date

Jan 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2013

Last Update Posted Date

Jan 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Abedini, associate professor of neurology, Mazandaran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mazandaran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Active Comparator	treatment with weekly 50000IU vitamin D	Drug: Vitamin D
Placebo	Placebo Comparator	Treatment with placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug		Vitamin D
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expanded disability state scale score (EDSS)		Changes in EDSS from baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Annual relapse rate(ARR)		Changes in ARR from baseline to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Past history of heart disease
Major depression
Uncontrolled hypertension (BP>180/110)
Immunosuppressive therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Abedini, MD	Contact	01513243158		mahmoudabedini@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mazandaran University of medical sciences		Sari	Mazandaran		Iran

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided